FDA Adverse Event
Injury
Summary report: N
INFUSE BONE GRAFT
MDR report key: 1951210
·
Received January 6, 2011
Report
- Report Number
- 1030489-2011-00013
- Event Type
- Injury
- Date Received
- January 6, 2011
- Report Date
- December 9, 2010
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- NEK
- PMA / PMN Number
- P000058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
LITERATURE ARTICLE CITATION: PATIL S. CLINICAL AND RADIOLOGICAL OUTOMES OF AXIAL LUMBAR INTERBODY FUSION. DOI: 10.3928/01477447-20 101021-05. (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THAT PATIENT UNDERWENT AN AXIAL LUMBAR INTERBODY FUSION. THE PATIENT REPORTED INCREASED PAIN ON POSTOPERATIVE DAY 3, AND A CT SCAN SHOWED A PELVIC HEMATOMA. THE PATIENT WAS MONITORED WEEKLY AND AN ABDOMINAL CT SCAN CONFIRMED THAT THE PELVIC HEMATOMA HAD ABSORBED 4 MONTHS POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |