FDA Adverse Event
Malfunction
Summary report: N
CANNULATED COMPRESSION SCREW
MDR report key: 2013826
·
Received February 4, 2011
Report
- Report Number
- 8010177-2011-00036
- Event Type
- Malfunction
- Date Received
- February 4, 2011
- Date of Event
- January 12, 2011
- Report Date
- January 13, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS FREIBURG
- Product Code
- HRS
- PMA / PMN Number
- K013775
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IN PROCESS BUT NOT YET COMPLETE.
Description of Event or Problem · 1
STRYKER REP IN (B)(6) REPORTED THAT IN THE TWIN FIX SURGERY THERE WERE TWO TWIN FIX SCREWS DEFECTIVE. AT THE TIME OF SURGERY, THE SCREWS WERE BROKEN IN DIFFERENT AREAS. DURING THE SURGERY A REPLACEMENT WAS AVAILABLE. THE SURGEON DECIDED TO USE THE REPLACEMENTS INSTEAD OF THE BROKEN SCREWS. ANOTHER DISTRIBUTOR OFFERED THE REPLACEMENT SCREWS. BOTH SCREWS WERE IN THE SAME SURGERY. FINALLY, THE DOCTOR GOT TO CUT OUT THE BONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CANNULATED COMPRESSION SCREW | IMPLANT | HRS | STRYKER OSTEOSYNTHESIS FREIBURG | NA | LAK00F0E84 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |