FDA Adverse Event
Injury
Summary report: N
6.5 CANCELLOUS BONE SCREW 35MM
MDR report key: 1132057
·
Received August 21, 2008
Report
- Report Number
- 2249697-2008-00243
- Event Type
- Injury
- Date Received
- August 21, 2008
- Date of Event
- July 29, 2008
- Report Date
- July 29, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- HWC
- PMA / PMN Number
- K873251
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVAL ANTICIPATED, BUT NOT YET BEGUN. IF DEVICE BECOMES AVAILABLE WITH ADD'L INFO, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT, " THE PT EXPERIENCED INTERMITTENT GROIN DISCOMFORT IN 2008, AND WAS TAKEN TO THE EMERGENCY ROOM. THE ENCLOSED X-RAYS SHOW THAT THE SCREW HAD BROKEN POST OPERATIVELY. THE PT DID NOT EXPERIENCE A FALL OR ANY OTHER TRAUMA."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6.5 CANCELLOUS BONE SCREW 35MM | IMPLANT | HWC | STRYKER ORTHOPAEDICS MAHWAH | NA | TL6MPA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention |