FDA Adverse Event
Injury
Summary report: N
PALMAR RADIUS FRACTURE PLATE, LOCKING, MEDIUM, RIG
MDR report key: 2031398
·
Received March 23, 2011
Report
- Report Number
- 8010177-2011-00081
- Event Type
- Injury
- Date Received
- March 23, 2011
- Date of Event
- January 15, 2011
- Report Date
- February 28, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS FRIEBURG
- Product Code
- HRS
- PMA / PMN Number
- K040022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT YET RETURNED FOR ANALYSIS. INVESTIGATION IN PROCESS, BUT NOT YET COMPLETE.
Description of Event or Problem · 1
SURGEON REPORTED VIA OUR SALES REP THAT PLATE FAILED / BENT IN SECOND HOLE ROW. FURTHER THE SURGEON REPORTED THAT DURING PRIMARY SURGERY THE PLATE WAS FIXED IN THE FIRST HOLE ROW, SECOND ROW WAS NOT FIXED. ALSO SURGEON MENTIONED THAT THE PT SUFFERED FROM PAIN AND SURGEON RECOGNIZED THAT THE PLATE WAS BENT. THEREFORE, A REVISION SURGERY WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PALMAR RADIUS FRACTURE PLATE, LOCKING, MEDIUM, RIG | IMPLANT | HRS | STRYKER OSTEOSYNTHESIS FRIEBURG | NA | LCH00F1773 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Other |