FDA Adverse Event
Malfunction
Summary report: N
TARGET DEVICE, HUMERUS
MDR report key: 1984022
·
Received January 14, 2011
Report
- Report Number
- 9610622-2011-00016
- Event Type
- Malfunction
- Date Received
- January 14, 2011
- Date of Event
- December 21, 2010
- Report Date
- December 22, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SAME PT EVENT AS MDR 9610622-2011-00017.
Description of Event or Problem · 1
IT WAS REPORTED VIA OUR SALES REP THAT THE NAIL HOLDING SCREW COULD NOT BE INSERTED INTO THE TARGET DEVICE. THE SURGERY WAS FINISHED USING AN ALTERNATIVE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TARGET DEVICE, HUMERUS | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | KME900983 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |