4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/RIGHT
Report
- Report Number
- 8030965-2013-01291
- Event Type
- Injury
- Date Received
- April 2, 2013
- Report Date
- March 4, 2013
- Manufacturer
- SYNTHES GMBH
- Product Code
- HRS
- PMA / PMN Number
- K110354
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADDITIONAL INFORMATION. THE PLATE WAS SLIGHTLY BENT; 5 OF 19 THREADED LOCKING HOLES ARE DAMAGED WHAT COMPLIES TO THE 5 LOCKING HEAD SCREWS WHICH ARE ALSO PART OF THIS COMPLAINT. BECAUSE OF THE DAMAGE, THE COMPLAINT RELEVANT DIMENSIONS CAN NOT BE CHECKED FOR DIMENSIONAL ACCURACY OF THE VALID MANUFACTURING SPECIFICATIONS. ALL OTHER INTACT THREADED LOCKING HOLES PASSED THE FUNCTIONAL TEST WITH A NEW 5.0MM VA LOCKING HEAD SCREW. THE SCREW COULD BE SUCCESSFULLY LOCKED AND UNLOCKED IN THE INTACT THREADED LOCKING HOLES.
DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADD'L PRO CODES: JDP, HWC. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RECEIVED AND THE INVESTIGATION IS ONGOING.
PATIENT WAS IMPLANTED WITH VA CONDYLAR PLATE AND SCREWS, DATE UNKNOWN. PATIENT RETURNED TO SURGEON AND COMPLAINED OF LEG SHORTENING, ROTATION. AN X-RAY SHOWED THAT 4 OUT OF THE 5 LOCKING SCREWS WERE LOOSENED AND BACKING OUT OF THE PLATE. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013 FOR PLATE SCREW REMOVAL. PATIENT WAS REVISED TO A 4.5MM LCP CURVED CONDYLAR PLATE. THIS IS 6 OF 6 REPORTS FOR THIS EVENT.
THIS IS 6 OF 6 REPORTS FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134674 | 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/RIGHT | HRS | SYNTHES GMBH | 7741678 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |