FDA Adverse Event
Injury
Summary report: N
CAPSTONE SPINAL SYSTEM
MDR report key: 2882607
·
Received December 20, 2012
Report
- Report Number
- 1030489-2012-02913
- Event Type
- Injury
- Date Received
- December 20, 2012
- Report Date
- November 20, 2012
- Manufacturer
- MDT SOFAMOR DANEK PUERTO RICO MFG
- Product Code
- MAX
- PMA / PMN Number
- K073291
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. LATERAL VIEW OF L5-S1 FUSION WITH INTERBODY DEVICE AND PEDICLE SCREWS. SOLID FUSION HAS NOT OCCURRED. SOME SCALLOPING OF THE END PLATES ABOVE AND BELOW SPACER IS NOTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE AT L5-S1 TO TREAT LUMBAR DISC HERNIATION. IT WAS REPORTED THAT EROSION SEEMED TO HAVE OCCURRED BETWEEN L5 AND S1. THE PATIENT IS ASYMPTOMATIC. NO REVISION SURGERY IS UNDER CONSIDERATION AT THIS MOMENT. NO BONE FUSION OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSTONE SPINAL SYSTEM | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR | MAX | MDT SOFAMOR DANEK PUERTO RICO MFG | NA | H11K1217 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00030 YR | Other |