FDA Adverse Event
Injury
Summary report: N
INFUSE BONE GRAFT
MDR report key: 1574865
·
Received January 8, 2010
Report
- Report Number
- 1030489-2010-00013
- Event Type
- Injury
- Date Received
- January 8, 2010
- Report Date
- December 9, 2009
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC.
- Product Code
- NPZ
- PMA / PMN Number
- P050053
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADDITIONAL PRODUCT INFORMATION. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OMF SURGERY WHERE RHBMP-2/ACS WAS USED IN THE MANDIBLE TO PROMOTE BONEY GROWTH FOR DENTAL IMPLANTS. THE PATIENT REPORTS SIGNIFICANT SWELLING POST OP, ACCOMPANIED BY DISCOMFORT. REPORTEDLY, SOME SWELLING STILL REMAINS 3.5 MONTHS POST OP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFUSE BONE GRAFT | INFUSE BONE GRAFT | NPZ | MEDTRONIC SOFAMOR DANEK USA, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |