FDA Adverse Event
Malfunction
Summary report: N
VERTEX® RECONSTRUCTION SYSTEM
MDR report key: 3915709
·
Received July 7, 2014
Report
- Report Number
- 1030489-2014-03020
- Event Type
- Malfunction
- Date Received
- July 7, 2014
- Report Date
- June 9, 2014
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- KWP
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
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 POSTERIOR CERVICAL FUSION AT C2-T1. SOMETIME POST-OP IT WAS REPORTED THAT THE C2 SET SCREW DISENGAGED FROM THE BONE SCREW. FUSION HAS NOT OCCURRED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 393270 | VERTEX® RECONSTRUCTION SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | MEDTRONIC SOFAMOR DANEK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |