FDA Adverse Event
Injury
Summary report: N
RADIAL CAP RHEAD HEAD AND STEM
MDR report key: 1739534
·
Received June 25, 2010
Report
- Report Number
- 3003640913-2010-00019
- Event Type
- Injury
- Date Received
- June 25, 2010
- Date of Event
- April 1, 2010
- Report Date
- June 25, 2010
- Manufacturer
- SMALL BONE INNOVATIONS, INC.
- Product Code
- JDB
- PMA / PMN Number
- K060038
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADD'L EXPIRATION DATE: 6/2014. ADDITIONAL DEVICE MANUFACTURE DATE: 06/2009. DIMENSIONAL EVALUATION SHOWED DEVICES WITHIN SPECIFICATION. VISUAL EXAMINATION SHOWED MARKS IN HEAD COMPONENT CONSISTENT WITH CANTILEVER FORCE APPLIED LATERALLY. THIS IS CONSISTENT WITH SUBLUXATION OF RADIAL HEAD BENEATH CAPITELLUM IN VIVO.
Description of Event or Problem · 1
PATIENT HAD A RADIAL HEAD DISASSOCIATE IN VIVO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RADIAL CAP RHEAD HEAD AND STEM | PROSTHESIS, ELBOW, HEMI, RADIAL, POLYME | JDB | SMALL BONE INNOVATIONS, INC. | 410-0009/RCN-S4 | 36209001/21534801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Required Intervention |