FDA Adverse Event
Malfunction
Summary report: N
VENTURE ANTERIOR CERVICAL PLATE SYSTEM
MDR report key: 2020763
·
Received March 16, 2011
Report
- Report Number
- 1030489-2011-00291
- Event Type
- Malfunction
- Date Received
- March 16, 2011
- Report Date
- February 15, 2011
- Manufacturer
- WARSAW ORTHOPEDIC, INC.
- Product Code
- KWP
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, 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. SOMETIME POST-OP, IT WAS REPORTED THAT A BONE SCREW BACKED OUT. A REVISION SURGERY HAS NOT BEEN PLANNED AT THIS TIME. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENTURE ANTERIOR CERVICAL PLATE SYSTEM | KWP | WARSAW ORTHOPEDIC, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |