FDA Adverse Event
Malfunction
Summary report: N
CLOSED TUBE CLIP
MDR report key: 2020528
·
Received February 16, 2011
Report
- Report Number
- 9610622-2011-00067
- Event Type
- Malfunction
- Date Received
- February 16, 2011
- Date of Event
- January 29, 2011
- Report Date
- January 29, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE REPORTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED, THE SURGEON ATTACHED THE CLOSED TUBE CLIP TO THE GAMMA DEVICE AND PROCEEDED TO INSERT THE SET SCREW. THE SET SCREW ENDED UP IN THE PATIENT. THE SURGEON WAS ABLE TO RECOVER THE SET SCREW FROM THE PATIENT. THE TIP OF THE CLOSED CLIP TUBE WAS BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLOSED TUBE CLIP | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Other |