FDA Adverse Event
Injury
Summary report: N
INFUSE BONE GRAFT
MDR report key: 3161633
·
Received June 11, 2013
Report
- Report Number
- 1030489-2013-02142
- Event Type
- Injury
- Date Received
- June 11, 2013
- Report Date
- September 26, 2016
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- NEK
- PMA / PMN Number
- P000058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED BY A NON-MEDICAL PROFESSIONAL THAT THE PATIENT UNDERWENT A PROCEDURE FOR SPINAL FUSION IMPLANTING RHBMP-2/ACS AT MULTIPLE LEVELS WITH AUTOGRAFT, ALLOGRAFT, AND PEEK GRAFT. SUBSEQUENTLY, THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBMP-2/ACS, CHRONIC PAIN, AND ADDITIONAL SURGERIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 262005 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00051 YR | Required Intervention |