PYRAMESH C TITANIUM MESH
Received Aug 12, 2011
Report 1030489-2011-01049 · MDR key 2210221
Device
Generic name
Mesh, Metal
Manufacturer
Warsaw Orthopedic, Inc.Model number
NACatalog number
G905H403
Lot number
W07B3764
Product problems
- Collapse
Patient
00075 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE USING INTERBODY DEVICE, ANTERIOR FIXATION PLATE SCREWS VIA ACF. IT WAS REPORTED THAT THE PLATE HAD BEEN BACKED OUT POST OP. SINKING OF CAGE WAS OBSERVED TOO. THE REVISION SURGERY WAS PERFORMED. THE PLATE AND SCREWS WERE REMOVED, AND EXTERNAL FIXATION WAS PERFORMED.
Additional Manufacturer Narrative
(B)(4). ANTERIOR FIXATION PLATE AND SCREWS, IMPLANT DATE UNKNOWN. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 905-403, 510K # K011406 WAS CLEARED IN THE UNITED STATES. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.