PATIENT?S WEIGHT WAS NOT PROVIDED FOR REPORTING. DATE OF EVENT IS UNKNOWN. ADDITIONAL DEVICE PRODUCT CODE: MQP. DEVICE REMAINED IMPLANTED. EXPLANT DATE IS NOT APPLICABLE. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. ADDITIONALLY, DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
D
Patient 1
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT A CERVICAL CORPECTOMY. PATIENT WAS IMPLANTED WITH ONE SYNMESH CAGE, TWO END RINGS (ASSOCIATED WITH SEGMENT ARTHRODESIS), ONE VECTRA TITANIUM (2-LEVEL) PLATE, AND FOUR 4.0MM TITANIUM CERVICAL SPINE SCREWS. POST-OPERATIVE, PATIENT EXPERIENCED IMPLANT PULL OUT OF THE 18MM SCREWS. THE FAILURE OF THE FIXATION WAS DETECTED ON (B)(6) 2018. SYMPTOMS PRESENTED IN THE POSTOPERATIVE PERIOD WAS MILD DYSPHONIA. DUE TO HIGH INSTABILITY AND RISK OF SPINAL CORD INJURY, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2018. DURING THE REVISION, SURGEON REMOVED THE VECTRA PLATE AND SCREWS, REPOSITIONED THE IMPLANTS SYNMESH AND PLACED ANOTHER NON-SYNTHES SYSTEM CONSISTING OF AN ANTERIOR PLATE AND CERVICAL SCREWS. AFTER THE PROCEDURE, IT WAS NOTED THAT THE FIXATION WAS NOT SATISFACTORY, AND THE PATIENT WAS REVISED ON (B)(6) 2018 FOR COMPLEMENTATION OF CERVICAL FIXATION POSTERIORLY. DURING THE SURGERY, LATERAL BONE SCREWS (AXON DEPUY SYSTEM) WERE PLACED ON THE VERTEBRAE C5-C6-C7 VERTEBRAE. POSTOPERATIVELY, APPROXIMATELY AROUND (B)(6) 2018 PATIENT WAS NOTED TO BE STILL DYSPHONIC BUT WITH CERVICAL STABILITY. REVIEW OF PROVIDED IMAGES BY MANUFACTURER NOTED THAT THE LOWER TWO SCREWS HAVE PULLED OUT ALLOWING THE PLATE TO ANTERIORLY PULL AWAY FROM THE BONE IN THE LOWER VERTEBRAL BODY AND THUS THE CAGE HAS ALSO DISLODGED ANTERIORLY. CONCOMITANT DEVICES REPORTED: 4.0MM TITANIUM CERVICAL SELF-RETAINING SCREW SELF-DRILLING VARIABLE ANGLE 18MM (PART # 04.613.518, LOT # 7537445, QUANTITY 2); END RING 15MM DIAMETER/ 0 DEGREE TITANIUM (PART # 495.386, LOT # 7882139, QUANTITY 2). THIS REPORT IS FOR ONE (1) SYNMESH? 15MM DIA 32MM HEIGHT (TI). THIS IS REPORT 3 OF 4 FOR (B)(4).