FDA Adverse Event
Other
Summary report: N
RHEAD LATERAL HEAD
MDR report key: 2428847
·
Received January 6, 2012
Report
- Report Number
- 3003640913-2012-00001
- Event Type
- Other
- Date Received
- January 6, 2012
- Date of Event
- November 22, 2011
- Report Date
- January 6, 2012
- Manufacturer
- SMALL BONE INNOVATIONS
- Product Code
- KWI
- PMA / PMN Number
- K062898
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EXPLANTED. DISTRIBUTOR STATED THAT THE CAUSE OF DISASSOCIATION WAS A FRACTURE OF THE TAB. IMPLANT WAS NOT RETURNED TO CONFIRM THE FRACTURE.
Description of Event or Problem · 1
DISASSOCIATION OF THE RADIAL RHEAD LATERAL IMPLANT FROM THE HEAD FROM THE STEM. HEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RHEAD LATERAL HEAD | RADIAL HEAD | KWI | SMALL BONE INNOVATIONS | 310-0009 | 22288801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |