FDA Adverse Event
Injury
Summary report: N
UNKNOWN
MDR report key: 3951010
·
Received July 22, 2014
Report
- Report Number
- 0001825034-2014-06319
- Event Type
- Injury
- Date Received
- July 22, 2014
- Report Date
- June 23, 2014
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- HSB
- PMA / PMN Number
- PUNKNOWN
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THERE HAS BEEN AN ALLEGED NON-UNION OF THE PHEONIX RETROGRADE NAIL. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE. AN INVOICE HISTORY COULD NOT BE LOCATED TO CONFIRM THE SURGERY DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 427584 | UNKNOWN | ROD, FIXATION | HSB | BIOMET ORTHOPEDICS | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |