FDA Adverse Event
Injury
Summary report: N
PLATE
MDR report key: 2963949
·
Received February 15, 2013
Report
- Report Number
- 2520274-2013-00989
- Event Type
- Injury
- Date Received
- February 15, 2013
- Report Date
- January 19, 2013
- Manufacturer
- SYNTHES USA
- Product Code
- HRS
- PMA / PMN Number
- K110354
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
Description of Event or Problem · 1
THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Description of Event or Problem · 1
PATIENT WAS IMPLANTED WITH PLATE AND SCREWS ON (B)(6) 2013 FOR AN ORIF OF FEMUR FRACTURE. PATIENT PRESENTED WITH PAIN POST-OPERATIVELY. IT WAS REPORTED THAT THE SURGEON HAD CONTOURED THE PLATE PRIOR TO IMPLANTATION. SUBSEQUENTLY, PATIENT WAS RETURNED TO THE OPERATING ROOM ON AN UNKNOWN DATE FOR REMOVAL OF PLATE AND SCREWS AND REPLACEMENT OF NEW HARDWARE. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 67555 | PLATE | HRS | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |