Table 1.
Complaints (USA) reported to manufacturer between January 1, 2015, and June 30, 2018
| Complaint type | 2015 | 2016 | 2017 | 2018 |
|---|---|---|---|---|
| Revision surgery | 140 | 101 | 138 | 56 |
| Pain complaints (general) | 69 | 56 | 33 | 15 |
| Instrument issue | 59 | 47 | 47 | 30 |
| Hematoma/seroma/bleeding | 4 | 2 | 3 | 2 |
| Other medical procedures | 4 | 0 | 2 | 0 |
| Embolism/aneurysm/DVT | 3 | 0 | 0 | 0 |
| iFuse use problem | 2 | 0 | 0 | 0 |
| Allergy (metal) | 1 | 0 | 1 | 0 |
| Bone fracture | 1 | 1 | 0 | 0 |
| iFuse implant product problem | 1 | 1 | 1 | 2 |
| Intraoperative issues | 1 | 0 | 1 | 0 |
| Off-label use | 1 | 2 | 3 | 0 |
| Others | 1 | 0 | 1 | 0 |
| Cardiac incident | 0 | 3 | 0 | 0 |
| Infection | 0 | 1 | 0 | 1 |
| Instrument use problem | 0 | 0 | 0 | 1 |
Abbreviation: DVT, deep venous thrombosis.