FDA Adverse Event
Injury
Summary report: N
VENTURE ANTERIOR CERVICAL PLATE SYSTEM
MDR report key: 2120599
·
Received June 10, 2011
Report
- Report Number
- 1030489-2011-00721
- Event Type
- Injury
- Date Received
- June 10, 2011
- Report Date
- May 11, 2011
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- KWQ
- PMA / PMN Number
- K042922
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- 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 AN ANTERIOR CERVICAL DISCECTOMY FUSION AT C4-6. IT WAS REPORTED THAT AT SOMETIME POST-OP THE BONE SCREW BACKED OUT OF THE PLATE. THE PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY 4 MONTHS POST-OP AND WAS REINSTRUMENTED DUE TO A NON-UNION. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENTURE ANTERIOR CERVICAL PLATE SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWQ | MEDTRONIC SOFAMOR DANEK | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | PLATES, SCREWS |