FDA Adverse Event
Injury
Summary report: N
TIBIAL NAIL, STANDARD T2 TIBIA 9X300 MM
MDR report key: 2801490
·
Received October 12, 2012
Report
- Report Number
- 9610622-2012-00459
- Event Type
- Injury
- Date Received
- October 12, 2012
- Date of Event
- September 27, 2012
- Report Date
- September 27, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K003018
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ADDITIONAL DEVICES: LOCKING SCREW = REF (B)(4) - LOT K115562, LOCKING SCREW = REF (B)(4) - LOT K239145, LOCKING SCREW = REF (B)(4) - LOT K237616.
Description of Event or Problem · 1
THE PHARMACIST AT THE HOSPITAL, REPORTED TO, SALES REP THAT "A TIBIAL T2 NAIL FRACTURED AT THE DISTAL SIDE 3 MONTHS AFTER THE PRIMARY SURGERY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TIBIAL NAIL, STANDARD T2 TIBIA 9X300 MM | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K550958 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other| R |