FDA Adverse Event
Malfunction
Summary report: N
6.5 CANCELLOUS BONE SCREW 30MM
MDR report key: 2170818
·
Received June 22, 2011
Report
- Report Number
- 2249697-2011-00942
- Event Type
- Malfunction
- Date Received
- June 22, 2011
- Date of Event
- May 31, 2011
- Report Date
- May 31, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- HWC
- PMA / PMN Number
- K873251
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE OTHER SCREW REPORTED IN THIS EVENT WAS 6.5 CANCELLOUS BONE SCREW 20MM, CATALOG # 2030-6520-1, LOT # UNK. IT WAS NOT SPECIFIED WHICH SCREW WAS ASSOCIATED WITH THE REPORTED EVENT. WHEN THE INVESTIGATION IS COMPLETED THE RESULTS WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "DURING THE REVISION SURGERY, WHEN THE SURGEON WAS REMOVING THE SCREW, HE NOTICED SOME METAL FRAGMENTS ON THE SCREW."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6.5 CANCELLOUS BONE SCREW 30MM | IMPLANT | HWC | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other |