FDA Adverse Event
Malfunction
Summary report: N
MSD-UNKNOWN IMPLANT
MDR report key: 1150907
·
Received September 3, 2008
Report
- Report Number
- 1030489-2008-00480
- Event Type
- Malfunction
- Date Received
- September 3, 2008
- Date of Event
- June 27, 2008
- Report Date
- August 4, 2008
- Manufacturer
- WARSAW ORTHOPEDIC INC.
- Product Code
- KWP
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION. UNABLE TO DETERMINE CAUSE OF THE EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT DIAGNOSED WITH FLAT BACK SYNDROME UNDERWENT SURGERY FOR L3 OSTEOTOMY AND T10-S1 POSTERIOR SPINAL FUSION. TWO WEEKS LATER, THE PATIENT UNDERWENT ADDITIONAL SURGERY FOR L4-S1 ANTERIOR LUMBAR FUSION. APPROXIMATELY 3 1/2 MONTHS POST-OP, X-RAYS REVEALED A FRACTURED RIGHT SIDED ROD NEAR THE OSTEOTOMY SITE. NO REVISION SURGERY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MSD-UNKNOWN IMPLANT | ROD | KWP | WARSAW ORTHOPEDIC INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR |