SYNMESH 15MM DIA 32MM HEIGHT (TI)

Additional Manufacturer Narrative

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.

Description of Event or Problem

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).

Additional Manufacturer Narrative

DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED. PART# 495.365 LOT# H168354 MFG DATE: 16 AUGUST 2016 MFG LOCATION: ELMIRA SYNTHES USA EXPIRATION DATE: N/A NOTED NONCONFORMANCES: N/A DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF SYNMESH 15MM DIAMETER 32MM HEIGHT (TI) PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK NOR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. H6: DEVICE EVALUATION: INVESTIGATION TYPE: IMAGE. NOTE: THE REPORTED IMPLANTS WERE NOT RETURNED FOR EVALUATION. THUS, THE FOLLOWING INVESTIGATION IS BASED ON THE PROVIDED IMAGES. 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. BASED ON REVIEW OF THE IMAGES, THE COMPLAINT CONDITION IS CONFIRMED AND CONSISTENT WITH THE REPORTED CONDITION AS THE PLATE (04.613.134), THE TWO SCREWS (04.613.518), AND THE CAGE (495.365) WERE OBSERVED TO HAVE MIGRATED AS REPORTED. THE RELEVANT DRAWING, REFLECTING THE CURRENT AND MANUFACTURED REVISION, WAS REVIEWED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. NO PHYSICAL INVESTIGATION (SUCH AS DIMENSIONAL INSPECTION) COULD BE COMPLETED AS THE DEVICES WERE NOT RETURNED. CONCLUSION: A DEVICE INSPECTION VIA THE PROVIDE X-RAYS WAS PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT CONDITION IS CONFIRMED AS THE PLATE (04.613.134), THE TWO SCREWS (04.613.518), AND THE CAGE (495.365) WERE OBSERVED TO HAVE MIGRATED AS REPORTED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED AS CIRCUMSTANCES SURROUNDING THE EVENT ARE UNKNOWN AND THE DEVICE WAS NOT RETURNED FOR PHYSICAL INSPECTION. FROM THE PROVIDED INFORMATION A DESIGN OR MANUFACTURING ISSUE WAS NOT IDENTIFIED. NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. THE RISK ASSESSMENT WAS FOUND TO ADEQUATELY ADDRESS THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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.

Additional Manufacturer Narrative

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.

Description of Event or Problem

THIS COMPLAINT (B)(4) CAPTURES THE EVENTS OF THE 3RD CASE, (B)(4) CAPTURES THE EVENTS OF THE 1ST CASE AND (B)(4) CAPTURES THE EVENTS OF THE 2ND CASE.