FDA Adverse Event
Injury
Summary report: N
VERTEX RECONSTRUCTION SYSTEM
MDR report key: 1639766
·
Received March 23, 2010
Report
- Report Number
- 1030489-2010-00339
- Event Type
- Injury
- Date Received
- March 23, 2010
- Date of Event
- April 30, 2007
- Report Date
- February 22, 2010
- Manufacturer
- MEDTRONIC SOFAMOR DANEK MFG
- Product Code
- KWP
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B) (4). LITERATURE ARTICLE CITATION: NOCKELS ET AL. OCCIPITOCERVICAL FUSION WITH RIGID INTERNAL FIXATION: LONG-TERM FOLLOW-UP DATA IN 69 PTS. J NEUROSURG SPINE. 2007; 7: 117-123. DEVICE HISTORY RECORDS COULD NOT BE REVIEWED WITHOUT ADDITIONAL INFO.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WITH CERVICAL DYSTONIA UNDERWENT SURGERY FOR OCCIPITOCERVICAL FUSION WITH RIGID INTERNAL FIXATION. ELEVEN MONTHS POST-OP, ONE OF THE CCJ PLATES BROKE. THE PT UNDERWENT A REVISION SURGERY TO REMOVE THE BROKEN PLATE. REMOVAL OF THE IMPLANT DID NOT HAVE A DELETERIOUS EFFECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERTEX RECONSTRUCTION SYSTEM | PLATE | KWP | MEDTRONIC SOFAMOR DANEK MFG | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |