PYRAMESH C TITANIUM MESH

Additional Manufacturer Narrative

THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 905-133, 510K # K011406 AND UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CERVICAL SPONDYLOTIC MYELOPATHY; AND UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION AT C4-C6 AND CORPECTOMY WAS PERFORMED AT C5. ON AN UNKNOWN DATE, POST-OP, SINKING OF THE REPORTED IMPLANT WAS OBSERVED. THE PATIENT SOMETIMES HAD A RIGHT SHOULDER PAIN AROUND THE TIME WHEN SINKING OF THIS IMPLANT WAS REPORTED. ADDITIONALLY, BACKING-OUT OF 4 SCREWS WAS ALSO REPORTED. HENCE, ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION SURGERY. IN THIS SURGERY, ALTHOUGH THERE WAS SINKING OF THE DEVICE, IT APPEARED TO BE FIT IN ITS POSITION; HENCE, IT WAS NOT REMOVED AND WAS LEFT IMPLANTED IN THE PATIENT'S BODY. THE 4 BACKED-OUT SCREWS WERE REMOVED AND LONGER SCREWS WERE INSERTED. THE ANTERIOR PLATE (THAT WAS INSERTED IN THE PREVIOUS SURGERY) CAME OFF TOGETHER WITH THE SCREWS AND WAS USED AGAIN BY PERFORMING FIXATION WITH LONGER SCREWS. "LMS" WAS INSERTED FROM POSTERIOR SIDE INTO C4-C6 AND WAS FASTENED WITH ROD AND CROSSLINK.