FDA Adverse Event
Malfunction
Summary report: N
LOCKING PEG, T7, DIAM.2.0X20MM
MDR report key: 6667458
·
Received June 26, 2017
Report
- Report Number
- 0008010177-2017-00137
- Event Type
- Malfunction
- Date Received
- June 26, 2017
- Date of Event
- June 8, 2017
- Report Date
- June 26, 2017
- Manufacturer
- STRYKER LEIBINGER FREIBURG
- Product Code
- HRS
- PMA / PMN Number
- K080667
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT DOCTOR HAD THE PLATE IN W/ SCREWS BUT WASN'T HAPPY W/ THE SCREW PLACEMENTS SO HE ATTEMPTED TO REMOVE THE SCREW, BUT THE SCREWS WOULD NOT RELEASE FROM THE PLATE. HE PULLED THE PLATE OUT W/ THE SCREWS ATTACHED AND PUT IN ANOTHER PLATE AND COMPLETED THE CASE SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 447302 | LOCKING PEG, T7, DIAM.2.0X20MM | PLATE, FIXATION, BONE | HRS | STRYKER LEIBINGER FREIBURG | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Other |