FDA Adverse Event
Injury
Summary report: N
LOCKING SCREW VARIAX FULL THREAD 2.7MM / L44MM
MDR report key: 2002519
·
Received February 16, 2011
Report
- Report Number
- 8031020-2011-00039
- Event Type
- Injury
- Date Received
- February 16, 2011
- Date of Event
- January 25, 2011
- Report Date
- January 25, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- KTT
- PMA / PMN Number
- K073527
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. SAME PATIENT EVENT AS MDR 8031020-2011-00038, 8031020-2011-00040.
Description of Event or Problem · 1
DOCTOR REPORTS VIA OUR SALES REP, THAT 3 LOCKING SCREWS LOOSENED AND REQUIRED REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LOCKING SCREW VARIAX FULL THREAD 2.7MM / L44MM | IMPLANT | KTT | STRYKER OSTEOSYNTHESIS SELZACH | NA | W26762 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |