Table 2.
Days from index surgery to complaint by complaint type and device type. In some cases, surgery or complaint dates were not available.
| Complaint type | Device type
|
|||||||
|---|---|---|---|---|---|---|---|---|
| iFuse, days from index surgery to complaint
|
iFuse-3D, days from index surgery to complaint
|
|||||||
| N | Mean | SD | Range | N | Mean | SD | Range | |
| Allergy (metal) | 2 | 151.5 | 204.4 | 7–296 | 0 | – | – | – |
| Bone fracture | 2 | 270.5 | 301.9 | 57–484 | 0 | – | – | – |
| Cardiac incident | 3 | 20.7 | 35.8 | 0–62 | 0 | – | – | – |
| Embolism/aneurysm/DVT | 3 | 24 | 16.1 | 11–42 | 0 | – | – | – |
| Hematoma/seroma/bleeding | 8 | 12 | 25.6 | 0–73 | 1 | 15 | – | – |
| iFuse implant product problem | 2 | 4.5 | 6.4 | 0–9 | 0 | – | – | – |
| iFuse use problem | 1 | 0 | – | – | 0 | – | – | – |
| Infection | 1 | 8 | – | – | 1 | 13 | – | – |
| Instrument issue | 31 | 126.5 | 362 | 0–1,529 | 0 | – | – | – |
| Instrument use problem | 0 | – | – | – | 0 | – | – | – |
| Intraoperative issues | 3 | 0.3 | 0.6 | 0–1 | 1 | 0 | – | – |
| Off-label use | 0 | – | – | – | 0 | – | – | – |
| Others | 1 | 965 | – | – | 0 | – | – | – |
| Other medical procedures | 5 | 609 | 177.8 | 413–819 | 0 | – | – | – |
| Pain complaints (general) | 151 | 520.3 | 376.8 | 3–1,651 | 3 | 41 | 52 | 2–100 |
| Revision surgery | 405 | 542.8 | 533.6 | 0–2,626 | 26 | 72.1 | 100.9 | 2–408 |
| All | 618 | 497.4 | 495.1 | 0–2,626 | 32 | 63.3 | 93.7 | 0–408 |
Note: Endashes indicate no value or statistic not calculable. In 4 cases, revision or index surgery dates were not known.
Abbreviation: DVT, deep venous thrombosis.