FDA Adverse Event
Injury
Summary report: N
HANSSON TWIN HOOK 95MM, OMEGA PLUS TI
MDR report key: 4150985
·
Received October 8, 2014
Report
- Report Number
- 0008031020-2014-00470
- Event Type
- Injury
- Date Received
- October 8, 2014
- Date of Event
- June 28, 2014
- Report Date
- September 12, 2014
- Manufacturer
- STRYKER TRAUMA SELZACH
- Product Code
- HTY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
AFTER GAMMA3 EXTRACTED, SUBCAPITAL FRACTURE OF FEMORAL NECK HAD OCCURRED. TWIN HOOK SURGERY WAS PERFORMED. BONE NECROSIS WAS FOUND 4 MONTHS AFTER THE REVISION. THIS CASE WAS PRESENTED AT THE MEETING OF (B)(4) SOCIETY FOR FRACTURE REPAIR ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 633507 | HANSSON TWIN HOOK 95MM, OMEGA PLUS TI | IMPLANT | HTY | STRYKER TRAUMA SELZACH | T126842 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |