FDA Adverse Event
Malfunction
Summary report: N
LOCKING SCREW ANCHORAGE Ø3.0MM / L12MM
MDR report key: 3982490
·
Received August 6, 2014
Report
- Report Number
- 0008031020-2014-00360
- Event Type
- Malfunction
- Date Received
- August 6, 2014
- Date of Event
- July 10, 2014
- Report Date
- July 15, 2014
- Manufacturer
- STRYKER TRAUMA SELZACH
- Product Code
- HRS
- PMA / PMN Number
- K083447
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: IT WAS IDENTIFIED DURING PREVIOUS CASES THAT THE SCREW IS CONCOMITANT FOR THIS REPORTED FAILURE (SCREW WENT THROUGH THE PLATE). IF ANY OTHER INFORMATION IS PROVIDED INDICATING OTHERWISE, THE INVESTIGATION WILL BE REWORKED.
Description of Event or Problem · 1
THE 3.0 X 12 LOCKING SCREW WENT THROUGH THE PLATE.
Description of Event or Problem · 1
THE 3.0 X 12 LOCKING SCREW WENT THROUGH THE PLATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 461620 | LOCKING SCREW ANCHORAGE Ø3.0MM / L12MM | PLATE, FIXATION, BONE | HRS | STRYKER TRAUMA SELZACH | F04130 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Other |