FDA Adverse Event
Injury
Summary report: N
INFUSE BONE GRAFT
MDR report key: 3171117
·
Received June 14, 2013
Report
- Report Number
- 1030489-2013-02306
- Event Type
- Injury
- Date Received
- June 14, 2013
- Report Date
- August 29, 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
ADD'L INFO.
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 L4-L5 FUSION WHERE RHBMP-2 WAS PLACED INSIDE AN INTERBODY CAGE AND IMPLANTED VIA A POSTERIOR APPROACH. POST-OP THE PATIENT ALLEGEDLY CONTINUED TO SUFFER FROM LOW BACK PAIN AND SIGNIFICANT LEG PAIN. A CT SCAN DEMONSTRATED LEFT FORAMINAL OVERGROWTH AT L4-L5. AS A RESULT, THE PATIENT HAS REQUIRED MEDICAL TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 270308 | 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 | 47 YR | Required Intervention |