FDA Adverse Event
Injury
Summary report: N
EBI XFIX DFS SYSTEM
MDR report key: 1123703
·
Received August 20, 2008
Report
- Report Number
- 2242816-2008-00121
- Event Type
- Injury
- Date Received
- August 20, 2008
- Date of Event
- July 27, 2008
- Report Date
- August 12, 2008
- Manufacturer
- EBI, L.P.
- Product Code
- KTT
- PMA / PMN Number
- K040935
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DHR FOR THE REPORTED LOT WAS REVIEWED AND NO DISCREPANCIES WERE OBSERVED. COMPLAINT HISTORY SEARCH FOUND NO OTHER REPORTED EVENTS OF THE REPORTED LOT.
Description of Event or Problem · 1
IT WAS REPORTED THAT BOTH PROXIMAL CORTICAL SCREWS HAVE BROKE POST HUMERAL EXTERNAL FIXATION OF AN OPEN FRACTURE. REVISION SURGERY (PLATE ORIF) WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EBI XFIX DFS SYSTEM | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT | KTT | EBI, L.P. | 336101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Required Intervention |