FDA Adverse Event
Injury
Summary report: N
PRODISC-C(TM) IMPLANT MEDIUM
MDR report key: 1910316
·
Received November 23, 2010
Report
- Report Number
- 2530088-2010-00215
- Event Type
- Injury
- Date Received
- November 23, 2010
- Report Date
- October 27, 2010
- Manufacturer
- SYNTHES BRANDYWINE
- Product Code
- MJO
- PMA / PMN Number
- P070001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED. DEVICE WILL NOT BE RETURNED TO SYNTHES FOR INVESTIGATION. INVESTIGATION IS ON GOING, NO CONCLUSION CAN BE DRAWN. REVIEW OF THE MFG RECORDS HAS BEEN REQUESTED.
Description of Event or Problem · 1
PRODISC-C IMPLANTED (B)(6) 2010. SURGEON NOTED POSTOP MIGRATION OF THE SUPERIOR ENDPLATE AND CONTINUED TO MONITOR PATIENT. F/U X-RAYS TAKEN (B)(6) 2010 PROMPTED SURGEON TO REMOVE DEVICE ON (B)(6) 2010 AND REVISE PATIENT TO OTHER HARDWARE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRODISC-C(TM) IMPLANT MEDIUM | PRODISC-C(TM) IMPLANT MEDIUM | MJO | SYNTHES BRANDYWINE | NA | 6278623 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |