FDA Adverse Event
Injury
Summary report: N
FEMORAL NAIL, A/R S2 10X380 MM
MDR report key: 2801701
·
Received October 12, 2012
Report
- Report Number
- 9610622-2012-00460
- 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
- K032579
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE SURGEON FROM THE EMERGENCY HOSPITAL (B)(6) REPORTED VIA STRYKER DISTRIBUTOR IN (B)(4) - THIRD PART - THAT "FEMORAL NAIL S2 WAS BROKEN SIX MONTH AFTER THE SURGERY. CONSOLIDATION WAS INSUFFICIENT. NAIL WAS REMOVED AND A NEW NAIL (S2 COMPRESSION NAIL) WAS IMPLANTED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FEMORAL NAIL, A/R S2 10X380 MM | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K245300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other| R |