FDA Adverse Event
Other
Summary report: N
TWIST DRILL DIAM. 1.3X50MM, WL 8MM, WITH STOP, STR
MDR report key: 1755934
·
Received July 14, 2010
Report
- Report Number
- 8010177-2010-00264
- Event Type
- Other
- Date Received
- July 14, 2010
- Date of Event
- June 17, 2010
- Report Date
- June 18, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS FEIBURG
- Product Code
- HBE
- PMA / PMN Number
- K070876
- 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 SCREW WAS TOO LOOSE TO FIX THE PLATE IN THE INVASIVE FIXED OPERATION FOR MAXILLA FRACTURE. THE SURGEON AND THE NURSE SAID, THE DRILL (B)(4) WHICH WAS USED TO DRILL THE HOLE HAD A BIGGER DIAMETER. THE SURGEON USED ANOTHER DRILL TO MAKE ANOTHER HOLE FOR THE PLATE, AND THE PLATE WAS FIXED COMPLETELY WITHOUT ANY PROBLEMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TWIST DRILL DIAM. 1.3X50MM, WL 8MM, WITH STOP, STR | INSTRUMENT | HBE | STRYKER OSTEOSYNTHESIS FEIBURG | NA | V10/EA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |