FDA Adverse Event
Malfunction
Summary report: N
WURZBURG MINI SCREWS, C-F, S-T, 1.7X8
MDR report key: 2191957
·
Received July 22, 2011
Report
- Report Number
- 8010177-2011-00209
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- June 24, 2011
- Report Date
- July 1, 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
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT 3 SCREWS FRACTURED DURING THE CASE. ONE OF THEM WAS NOT MENTIONED IN THE COMPLAINT, BECAUSE IT FRACTURED AS A RESULT OF MANIPULATION BY THE PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WURZBURG MINI SCREWS, C-F, S-T, 1.7X8 | IMPLANT | JEY | STRYKER OSTEOSYNTHESIS FREIBURG | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |