FDA Adverse Event
Injury
Summary report: N
2520274-2013-02088
MDR report key: 3073113
·
Received April 23, 2013
Report
- Report Number
- 2520274-2013-02088
- Event Type
- Injury
- Date Received
- April 23, 2013
- Date of Event
- November 6, 2012
- Report Date
- March 25, 2013
- Manufacturer
- SYNTHES USA
- Product Code
- HSB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.
Description of Event or Problem · 1
DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS IMPLANTED WITH PFNA BLADE AND NAIL ON AN UNKNOWN DATE. REPORTEDLY THE PFNA BLADE ADVANCED INTO THE PATIENTS JOINT. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR AN UNKNOWN NAIL. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 174667 | HSB | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Required Intervention |