FDA Adverse Event
Injury
Summary report: N
PLATE
MDR report key: 2854175
·
Received December 3, 2012
Report
- Report Number
- 2520274-2012-03472
- Event Type
- Injury
- Date Received
- December 3, 2012
- Report Date
- November 4, 2012
- Manufacturer
- SYNTHES (USA)
- Product Code
- JEY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PARAMEDIC
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO PART OR LOT NUMBER WAS PROVIDED.
Description of Event or Problem · 1
A REPORT WAS RECEIVED REGARDING THE REMOVAL OF A PLATE. THE SURGEON ELECTED TO REMOVE THE PLATE AND ASSOCIATED HARDWARE TO REPLACE IT WITH A TOTAL KNEE. THE PATIENT HAD PAIN AND THE SURGEON DETERMINED A TOTAL KNEE REPLACEMENT WOULD BE THE BEST OPTION FOR THE PATIENT. REPORTEDLY, NONE OF THE DEVICES REMOVED DURING THE EXPLANT HAD FAILED. THIS IS REPORT # 1 OF 10 FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLATE | PLATE | JEY | SYNTHES (USA) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |