FDA Adverse Event
Malfunction
Summary report: N
PLATE
MDR report key: 2556698
·
Received April 25, 2012
Report
- Report Number
- 2520274-2012-00528
- Event Type
- Malfunction
- Date Received
- April 25, 2012
- Report Date
- March 4, 2012
- Product Code
- HRS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVENT REPORTED TO SYNTHES USA ON (B)(6) 2012, SYNTHES FIRST AWARENESS DATE WAS (B)(6) 2012. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS DEVICE WAS NOT EXPLANTED AND THEREFORE, NOT RETURNED, AND PART NUMBER AND LOT NUMBER WERE NOT PROVIDED. ADD'L INFO WAS REQUESTED TWO TIMES AND HAS NOT BEEN RECEIVED.
Description of Event or Problem · 1
DEVICE REPORT RECEIVED FROM (B)(6) REPORTED A SURGEON REVIEWED A POST-OPERATIVE X-RAY AND NOTED THE 3.5 MM. RECONSTRUCTION PLATE WAS BROKEN. PT WAS NOT REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLATE | HRS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |