Table 6.
Adverse events.
| Patient number | Type of event | Time after surgery (days) | Relationship to device | Relationship to procedure | Outcome at 12 M |
|---|---|---|---|---|---|
| 11R01 | Death due to acute kidney failure aggravation with vascular obliteration of leg | 52 | No | No | Death |
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| 11R04 | Sigma diverticulitis (preexisting condition at inclusion) aggravation: hospitalization for diverticulitis resection | 8 | No | No | Resolved |
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| 11R07 | Asymptomatic adjacent vertebral fracture T11: No treatment needed (treated vertebra T12) | 99 | No | Yes | Ongoing (fracture remains stable) |
|
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| 13R06 | Prolongation of hospitalization for dislocation of posterior wall secondary to surgery which leads to sensorial deficit → surgery with wrong indication | 4 | No | Yes | Resolved |
| Breakage of screws in L3: recommendation of revision surgery but patient declined surgery | 82 | No | No | Ongoing Patient lost to follow-up |
|
|
| |||||
| 31R04 | Posterior articular conflict due to a discopathy L4/L5 grade IV associated to a degenerative spondylolisthesis grade II Meyerding | 147 | No | No | Resolved at Day 455 |
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| 31R05 | Algoneurodystrophic syndrome due to calcaneum fracture resolved by decompressive surgery | 100 | No | No | Resolved |
|
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| 31R06 | Prostatic cancer | 257 | No | No | Ongoing |
|
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| 31R15 | Bleeding at the point of the skin incision just after the surgery | 2 | No | No | Resolved |
|
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| 31R16 | Spontaneous adjacent fracture T12 (treated vertebra L1) in a context of major osteoporosis aggravation: hospitalization for vertebroplasty | 19 | No | No | Resolved |
| Spontaneous adjacent fracture L2 (treated vertebra L1) in a context of major osteoporosis aggravation treatment: analgesics and Zoledronic acid monohydrate | 49 | No | No | Patient discontinued | |
| Spontaneous new fracture L4 (treated vertebra L1) in a context of major osteoporosis aggravation treatment: analgesics and Zoledronic acid monohydrate | 86 | No | No | Patient discontinued | |
| Spontaneous new fracture L5 (treated vertebra L1) in a context of major osteoporosis aggravation treatment: analgesics and Zoledronic acid monohydrate | 86 | No | No | Patient discontinued | |
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| 35R08 | Death due to acute respiratory syndrome | 204 | No | No | Death |
|
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| 35R11 | Hospitalization in psychiatric department | Not available | No | No | Resolved |
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| 36R01 | Subsequent fracture at T12 level (previous treated level L2): hospitalization for vertebroplasty | 18 | No | No | Resolved |
| Subsequent fracture at T11 level (previous treated level L2): hospitalization for vertebroplasty | 126 | No | No | Resolved | |
| Adjacent fracture at L3 level (previous treated level L2): hospitalization for vertebroplasty | 126 | No | No | Resolved | |
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| 36R02 | Lumbar pain | 418 | No | No | Resolved |
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| 38R07 | Shoulder fracture due to a fall discovered lately and treated by physiotherapy | 276 | No | No | Ongoing |
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| 41R02 | Collapse of treated vertebral body associated with canal compromise and hematoma leading to neurological symptoms | 16 | No | Yes | Improved |