FDA Adverse Event
Malfunction
Summary report: N
COMPR./DISTR. ROD-ROD COUPLING HOFFMANN I COMPAC
MDR report key: 2444422
·
Received January 18, 2012
Report
- Report Number
- 8031020-2012-00011
- Event Type
- Malfunction
- Date Received
- January 18, 2012
- Date of Event
- November 29, 2011
- Report Date
- December 27, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- JEC
- PMA / PMN Number
- K971755
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, SURGEON WAS TIGHTENING AN EX-FIX BAR-TO-TUBE CLAMP AND THE CLAMP BROKE OR SUSPECTED IT BROKE. WE PUT ANOTHER ONE ON AND UNDER FURTHER EXAMINATION, THE CLAMP DID BREAK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMPR./DISTR. ROD-ROD COUPLING HOFFMANN I COMPAC | IMPLANT | JEC | STRYKER OSTEOSYNTHESIS SELZACH | NA | W06350 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |