FDA Adverse Event
Malfunction
Summary report: N
TITANIUM BONE SCREWS, CROSS-FIT, SELF-TAPPING, DIA
MDR report key: 2181145
·
Received July 8, 2011
Report
- Report Number
- 8010177-2011-00196
- Event Type
- Malfunction
- Date Received
- July 8, 2011
- Date of Event
- June 16, 2011
- Report Date
- June 16, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS FREIBURG
- Product Code
- HRS
- PMA / PMN Number
- K062498
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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 AFTER DRILLING, THE SCREW BROKE DURING INSERTION. THE TIP OF THE SCREW REMAINED IN THE PT'S BONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TITANIUM BONE SCREWS, CROSS-FIT, SELF-TAPPING, DIA | IMPLANT | HRS | STRYKER OSTEOSYNTHESIS FREIBURG | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |