FDA Adverse Event
Injury
Summary report: N
9MM TI STRAIGHT RADIAL STEM 30MM-STERILE
MDR report key: 2921408
·
Received January 17, 2013
Report
- Report Number
- 1719045-2013-00148
- Event Type
- Injury
- Date Received
- January 17, 2013
- Report Date
- December 19, 2012
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- KWI
- PMA / PMN Number
- K112030
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES.
Description of Event or Problem · 1
PATIENT WAS IMPLANTED WITH RADIAL HEAD CONSTRUCT ON (B)(6) 2012. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2012 FOR REMOVAL OF HARDWARE DUE TO SUBLUXATION. THERE WERE NO REPORTED PROBLEMS DURING THE SURGERY. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 26355 | 9MM TI STRAIGHT RADIAL STEM 30MM-STERILE | STRAIGHT RADIAL STEM | KWI | SYNTHES MONUMENT | 6955113 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention | COCR RADIAL HEAD |