FDA Adverse Event
Malfunction
Summary report: N
ROD TO ROD COUPLING HOFFMAN II COMPACT 5/5MM
MDR report key: 2003090
·
Received February 8, 2011
Report
- Report Number
- 8031020-2011-00034
- Event Type
- Malfunction
- Date Received
- February 8, 2011
- Date of Event
- January 26, 2011
- Report Date
- January 27, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- JEC
- PMA / PMN Number
- K952730
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
DURING SURGERY, WHEN THE ROD COUPLING IN THE DISPOSABLE KIT (STERILE) WAS USED, ONE OF THE SCREWS FROM THE ROD COUPLING WAS TIGHT AND DID NOT FUNCTION. THE SCREW DID NOT TURN. THE SURGEON USED PINCERS AND A WRENCH. THE SURGEON TEMPORARILY FIXED THE FRAME. THE SURGEON PLANS TO FIX THE FRAME BY USING A NEW ROD COUPLING LATER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ROD TO ROD COUPLING HOFFMAN II COMPACT 5/5MM | IMPLANT | JEC | STRYKER OSTEOSYNTHESIS SELZACH | NA | W29940 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |