FDA Adverse Event
Injury
Summary report: N
PRODISC-C IMPLANT MEDIUM
MDR report key: 2001693
·
Received February 22, 2011
Report
- Report Number
- 2530088-2011-00024
- Event Type
- Injury
- Date Received
- February 22, 2011
- Date of Event
- January 28, 2011
- Report Date
- January 28, 2011
- Manufacturer
- SYNTHES BRANDYWINE
- Product Code
- MJO
- PMA / PMN Number
- P070001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED. IMPLANT WAS NOT REMOVED. INVESTIGATION IS ONGOING. NO CONCLUSION CAN BE DRAWN.
Description of Event or Problem · 1
PRO-DISC-C WAS IMPLANTED AT C4-C5. TWO MONTHS POST IMPLANT, THE PRODISC WAS NOTED TO BE COMING LOOSE AND PATIENT WAS RETURNED TO THE OPERATING ROOM. THE LOOSE CONDITION WAS CORRECTED. THIS REPORT IS #1 OF 2 ON THE SAME DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRODISC-C IMPLANT MEDIUM | PRODISC-C IMPLANT MEDIUM | MJO | SYNTHES BRANDYWINE | NA | 6341718 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Required Intervention |