FDA Adverse Event
Malfunction
Summary report: N
LOCKING PLATE, SAGITTAL SPLIT, 12MM BAR, 6 HOLE, O
MDR report key: 2013750
·
Received February 4, 2011
Report
- Report Number
- 8010177-2011-00035
- Event Type
- Malfunction
- Date Received
- February 4, 2011
- Date of Event
- January 13, 2011
- Report Date
- January 13, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS FREIBURG
- Product Code
- JEY
- PMA / PMN Number
- K022185
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IN PROCESS, BUT NOT YET COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED ON (B)(6), 2009. AND IT WAS FOUND BY X-RAY THAT THE UNIT WAS BROKEN ON (B)(6) 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LOCKING PLATE, SAGITTAL SPLIT, 12MM BAR, 6 HOLE, O | IMPLANT | JEY | STRYKER OSTEOSYNTHESIS FREIBURG | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |