FDA Adverse Event
Malfunction
Summary report: N
STEPDRILL FOR LAG SCREW
MDR report key: 1062278
·
Received June 17, 2008
Report
- Report Number
- 9610622-2008-00090
- Event Type
- Malfunction
- Date Received
- June 17, 2008
- Date of Event
- May 28, 2008
- Report Date
- May 28, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSZ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "TIP OF DRILL BROKE DRILLING THROUGH DENSE BONE NEAR THE CALCAR REGION OF THE NECK. WERE ABLE TO RETRIEVE THE BROKEN TIP USING A HOOK DEVICE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEPDRILL FOR LAG SCREW | INSTRUMENT | HSZ | STRYKER OSTEOSYNTHESIS KIEL | NA | K548464 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |