FDA Adverse Event
Injury
Summary report: N
STAR TOTAL ANKLE REPLACEMENT
MDR report key: 3862737
·
Received May 27, 2014
Report
- Report Number
- 3003640913-2014-00038
- Event Type
- Injury
- Date Received
- May 27, 2014
- Date of Event
- April 21, 2014
- Report Date
- April 23, 2014
- Manufacturer
- SMALL BONE INNOVATIONS, INC.
- Product Code
- NTG
- PMA / PMN Number
- P050050
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DHR FOR PART NUMBER 400-140 LOT 0334064 NOTED THAT (B)(4) WERE DISCARDED. ALL RELATED PARTS WERE WITHIN SPECIFICATION. VISUAL EXAMINATION CONFIRMS THE SLIDING CORE MOBILE BEARING WAS FRACTURED.
Description of Event or Problem · 1
STAR TOTAL ANKLE REPLACEMENT SLIDING CORE MOBILE BEARING WAS EXCHANGED DUE TO IMPLANT FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311757 | STAR TOTAL ANKLE REPLACEMENT | SLIDING CORE MOBILE BEARING | NTG | SMALL BONE INNOVATIONS, INC. | 400-140 | 0334064 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |