FDA Adverse Event
Malfunction
Summary report: N
ANCHOR C 8MM INSERTER
MDR report key: 2822992
·
Received October 24, 2012
Report
- Report Number
- 9617544-2012-00457
- Event Type
- Malfunction
- Date Received
- October 24, 2012
- Date of Event
- September 26, 2012
- Report Date
- September 26, 2012
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- ODP
- PMA / PMN Number
- K102606
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED AND IF MADE AVAILABLE, WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "REP WAS RESTOCKING THE SET AND CHECKED THE INSERTERS. THE 7 MM AND 8 MM INSERTERS ARE NOT THREADING PROPERLY ONTO THE IMPLANTS. THE SET WAS USED IN A CASE ON (B)(6) 2012, BUT THE SURGEON DID NOT HAVE ANY PROBLEMS WITH THE INSERTERS DURING THE SURGERY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANCHOR C 8MM INSERTER | INSTRUMENT | ODP | STRYKER SPINE BORDEAUX | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |