FDA Adverse Event
Injury
Summary report: N
11MM TI CANNULATED FEMORAL NAIL 400MM
MDR report key: 3142333
·
Received June 3, 2013
Report
- Report Number
- 2520274-2013-02914
- Event Type
- Injury
- Date Received
- June 3, 2013
- Report Date
- May 7, 2013
- Manufacturer
- SYNTHES USA
- Product Code
- JDN
- PMA / PMN Number
- K954856
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- NURSE
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. ADDITIONAL INFORMATION: PATIENT ID - CASE #: (B)(6). PLACEHOLDER.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A SYNTHES TITANIUM FEMORAL NAIL AND TWO LOCKING SCREWS WAS REVISED DUE TO A BROKEN PROXIMAL DYNAMIC SCREW IN ADDITION TO A NON UNION. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 243225 | 11MM TI CANNULATED FEMORAL NAIL 400MM | JDN | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |