BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    MDR report key: 6998641 · Received November 3, 2017

    Report

    Report Number
    2520274-2017-12544
    Event Type
    Malfunction
    Date Received
    November 3, 2017
    Date of Event
    October 17, 2013
    Report Date
    October 4, 2017
    Manufacturer
    SYNTHES (USA)
    Product Code
    MQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT¿S IDENTIFICATION NOT AVAILABLE FOR REPORTING. PATIENT¿S HEIGHT REPORTED AS (B)(6). THIS REPORT IS FOR ONE (1) UNKNOWN SYNEX VERTERBRAL BODY REPLACEMENT, UNKNOWN PART # / LOT #. (OTHER NUMBER) UDI # UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. IMPLANTED DATE: IMPLANT DATE REPORTED AS (B)(6) 2007. EXPLANTED DATE: DEVICE NOT REPORTED AS EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. - (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: A. ROHLMANN ET AL. (2013). MONITORING THE LOAD ON A TELEMETERISED VERTEBRAL BODY REPLACEMENT FOR A PERIOD OF UP TO 65 MONTHS, EUR SPINE J (2013) 22:2575¿2581. GERMANY. THE STUDY OBJECTIVE WAS TO DETERMINE THE POSTOPERATIVE TEMPORAL COURSE OF THE FORCES ACTING ON A VERTEBRAL BODY REPLACEMENT FOR TWO WELL REPRODUCIBLE ACTIVITIES (STANDING AND WALKING). THE STUDY WAS COMPRISED OF FIVE PATIENTS (FOUR MALES AND ONE FEMALE) BETWEEN THE AGES OF 62-71 WHO HAD A3 TYPE COMPRESSION FRACTURES OF A VERTEBRAL BODY. IN FOUR PATIENTS, THE L1 VERTEBRAL BODY WAS FRACTURED, AND IN ONE PATIENT THE L3 VERTEBRAL BODY WAS FRACTURED. ALL PATIENTS WERE IMPLANTED WITH A MODIFIED SYNEX VERTEBRAL BODY REPLACEMENT (VBR). IMPLANT DATES RANGE FROM 2006-2008. IN A FIRST SURGERY, THE FRACTURE WAS STABILIZED FROM THE POSTERIOR USING AN INTERNAL SPINAL FIXATION DEVICE. LEVELS OF INTERNAL FIXATION RANGE FROM T11-L2. MANUFACTURER OF THE DEVICES IS UNKNOWN. IN A SECOND SURGERY, PARTS OF THE FRACTURED VERTEBRAL BODY AND THE ADJACENT INTERVERTEBRAL DISCS WERE REMOVED, AND THE VBR WAS INSERTED IN THE CORPECTOMY DEFECT. AUTOLOGOUS BONE MATERIAL WAS ADDED. INITIAL MEASUREMENTS STARTED 3¿7 DAYS AFTER SURGERY AND WERE REPEATED FOR UP TO 65 MONTHS. STANDING RELAXED AND WALKING WERE THE TWO EXERCISES EVALUATED IN THIS STUDY. FOR THE MEASUREMENTS, A COIL WAS PLACED AROUND THE PATIENT¿S TRUNK AT THE LEVEL OF THE IMPLANT TO SUPPLY POWER. AN ANTENNA ON THE PATIENT¿S BACK RECEIVED THE SIGNALS FROM THE TELEMETRY AND TRANSMITTED THEM TO A NOTEBOOK. THE AVERAGE RESULTANT FORCE OF THE FIVE PATIENTS DECREASED FOR THE DIFFERENT TIME PERIODS STUDIED RELATIVE TO THE VALUE MEASURED IN THE FIRST 2 MONTHS. ON AVERAGE, IT WAS 12 % LOWER AT THREE TO SIX POSTOPERATIVE MONTHS, 4 % LOWER AT 6¿12 POSTOPERATIVE MONTHS, 17 % LOWER IN THE SECOND YEAR, 22 % LOWER IN THE THIRD YEAR, AND 11 % LOWER THEREAFTER. HOWEVER, THERE WAS A GREAT INTER-INDIVIDUAL VARIATION. THE FOLLOWING COMPLICATIONS WERE REPORTED: ONE FEMALE PATIENT, AGE (B)(6) (WP3), HAD THE FORCE DECREASED WITHIN THE FIRST TWO (2) MONTHS WHICH CAN BE EXPLAINED BY A SLIGHT IMPLANT SUBSIDENCE. THIS IS REPORT 2 OF 3 FOR (B)(4). THIS REPORT IS FOR ONE (1) UNKNOWN SYNEX VERTERBRAL BODY REPLACEMENT, UNKNOWN PART # / LOT #.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780537 SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR