FDA Adverse Event
Injury
Summary report: N
SPINAL PEDICLE FIXATION
MDR report key: 3241114
·
Received July 22, 2013
Report
- Report Number
- 1030489-2013-03075
- Event Type
- Injury
- Date Received
- July 22, 2013
- Report Date
- June 24, 2013
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- NKB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.
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 THAT THE PATIENT UNDERWENT A PROCEDURE VIA TLIF TO TREAT ISTHMIC SPONDYLOLISTHESIS. IT WAS REPORTED THAT THE CAGE BACK-OUT WAS CONFIRMED 1 MONTH POST-OPERATIVE. A REVISION SURGERY WAS COMPLETED APPROXIMATELY 15 MONTHS POST OP DUE TO SCREW LOOSENING AND THE CAGE BACKING OUT.¿ NO ADDITIONAL PATIENT INFORMATION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 341399 | SPINAL PEDICLE FIXATION | ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE | NKB | MEDTRONIC SOFAMOR DANEK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00041 YR | Required Intervention |