FDA Adverse Event
Malfunction
Summary report: N
CRESCENT VERTEBRAL BODY SPACER
MDR report key: 1021054
·
Received March 28, 2008
Report
- Report Number
- 1030489-2008-00165
- Event Type
- Malfunction
- Date Received
- March 28, 2008
- Date of Event
- February 26, 2008
- Report Date
- February 27, 2008
- Manufacturer
- SOFAMOR DANEK DEGGENDORF GMBH
- Product Code
- MQP
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE HAS RETURNED TO MEDTRONIC FOR EVAL. EVAL HAS NOT BEEN COMPLETED BUT IS CURRENTLY IN PROGRESS. DEVICE HISTORY RECORDS HAVE BEEN REVIEWED WHICH FOUND NO DOCUMENTATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER FILLING THE IMPLANT WITH BONE, THE SURGEON ATTEMPTED TO IMPLANT THE SPACER WITH THE INSERTER. AFTER A FEW HAMMER HITS THE SPACER BROKE INTO FOUR PIECES WITH ONE PIECE STILL ATTACHED TO THE INSERTER. NO PT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRESCENT VERTEBRAL BODY SPACER | VERTEBRAL BODY SPACER | MQP | SOFAMOR DANEK DEGGENDORF GMBH | NA | ND73 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |