FDA Adverse Event
Other
Summary report: N
RHEAD LATERAL HEAD
MDR report key: 1584178
·
Received January 20, 2010
Report
- Report Number
- 3003640913-2010-00004
- Event Type
- Other
- Date Received
- January 20, 2010
- Date of Event
- November 25, 2009
- Report Date
- January 20, 2010
- Manufacturer
- SMALL BONE INNOVATIONS
- Product Code
- KWI
- PMA / PMN Number
- K062898
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT NOT EXPLANTED. NO ANOMALIES FOUND IN REVIEW OF MANUFACTURING RECORDS. NO CONCLUSION COULD BE DRAWN ON CAUSE OF DISASSOCIATION.
Description of Event or Problem · 1
A 1-2MM DISASSOCIATION OF THE RADIAL RHEAD LATERAL IMPLANT FROM THE HEAD FROM THE STEM SEEN ON X-RAY. NOT EXPLANTED. DISASSOCIATION NOT CAUSING PAIN OR LOSS OF FUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RHEAD LATERAL HEAD | RADIAL HEAD | KWI | SMALL BONE INNOVATIONS | 310-0009 | 12761 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |