FDA Adverse Event
Injury
Summary report: N
5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM F/IM NAIL-STER
MDR report key: 2870467
·
Received December 12, 2012
Report
- Report Number
- 1719045-2012-01342
- Event Type
- Injury
- Date Received
- December 12, 2012
- Report Date
- November 14, 2012
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- HSB
- PMA / PMN Number
- K000089
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DHR WAS REVIEWED WITH NO COMPLAINT RELATED ANOMALIES NOTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
Description of Event or Problem · 1
PATIENT WAS IMPLANTED WITH TIBIAL NAIL (B)(6) 2012 FOR TIBAIL SHAFT FRACTURE. PATIENT RETURNED TO OR WITH OPERATIVE SITE SEPTIC ARTHRITIS INFECTION ON (B)(6) 2012. SURGEON PERFORMED AN ARTHROSCOPIC LAVAGE AS TREATMENT PLAN. NO HARDWARE WAS REMOVED. THIS IS 3 OF 4 REPORTS FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM F/IM NAIL-STER | LOCKING SCREW | HSB | SYNTHES MONUMENT | 6992013 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Required Intervention | NAIL, SCREW |