FDA Adverse Event
Malfunction
Summary report: N
FIXED ANGLE DRILL GUIDE 2.3/2.7MM
MDR report key: 2993211
·
Received March 7, 2013
Report
- Report Number
- 0008010177-2013-00030
- Event Type
- Malfunction
- Date Received
- March 7, 2013
- Date of Event
- February 5, 2013
- Report Date
- February 12, 2013
- Manufacturer
- STRYKER OSTEOSYNTHESIS-FREIBURG
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.
Additional Manufacturer Narrative · 1
IT WAS STATED THAT THE CLAIMED PRODUCT WAS JUDGED TO BE FUNCTIONAL AND THE FACILITY DECIDED THAT THEY DID NOT WANT TO SEND IT BACK FOR EVALUATION. DEVICE NOT RETURNED.
Description of Event or Problem · 1
DURING SURGERY, THE SURGEON FELT BADNESS OF FITTING OF THE DRILL GUIDE.
Description of Event or Problem · 1
DURING SURGERY, THE SURGEON FELT BADNESS OF FITTING OF THE DRILL GUIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 97827 | FIXED ANGLE DRILL GUIDE 2.3/2.7MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS-FREIBURG | AA05 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |