FDA Adverse Event
Injury
Summary report: N
TENOR SPINAL SYSTEM
MDR report key: 2223447
·
Received August 25, 2011
Report
- Report Number
- 1030489-2011-01103
- Event Type
- Injury
- Date Received
- August 25, 2011
- Date of Event
- April 16, 2009
- Report Date
- July 26, 2011
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- KWP
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL SURGICAL PROCEDURE. APPROXIMATELY 4 YEARS POST OP THE PATIENT FELT LOWER BACK PAIN. IT WAS FOUND THAT THE SCREW WAS BROKEN AT THE EDGE OF THE LOWER SIDE. THE PATIENT UNDERWENT A REVISION SURGERY AND THE PRODUCT WAS EXPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENOR SPINAL SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | MEDTRONIC SOFAMOR DANEK | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |