FDA Adverse Event
Injury
Summary report: N
INFUSE BONE GRAFT
MDR report key: 1599305
·
Received February 5, 2010
Report
- Report Number
- 1030489-2010-00136
- Event Type
- Injury
- Date Received
- February 5, 2010
- Report Date
- January 6, 2010
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC.
- Product Code
- NPZ
- PMA / PMN Number
- P050053
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B) (4). A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE 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 A PATIENT COMPLAINED OF EXPERIENCING SWELLING IN COLD WEATHER AFTER RHBMP-2/ACS WAS IMPLANTED FOR AN OMF PROCEDURE FOR A CLEFT PALATE. THE PATIENT ALSO REPORTEDLY EXPERIENCED A RASH 6 MONTHS POST-OP. THE SURGEON DOES NOT BELIEVE THE EVENT WAS RELATED TO THE DEVICE.
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 |