BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    MDR report key: 8656480 · Received May 30, 2019

    Report

    Report Number
    8030965-2019-64706
    Event Type
    Malfunction
    Date Received
    May 30, 2019
    Report Date
    May 1, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    MQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR AN UNKNOWN SYNEX IMPLANT/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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. [(B)(4)].

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: UTA LANGE ET. AL (2002), VERTEBRAL BODY REPLACEMENT USING SYNEX, CURRENT TRAUMATOLOGY, VOL. 32(N), PAGES 1-7 (GERMANY). THE AIM OF THIS ARTICLE IS TO EVALUATE THE PROSPECTIVELY COLLECTED DATE OF THE FIRST PATIENTS STABILIZED WITH THE NEW VERTEBRAL BODY REPLACEMENT SYNEX. THIS WAS INTENDED TO PROVIDE INFORMATION ON THE EXACT INDICATION SPECTRUM OF THE SPACER AND TO IDENTIFY POSSIBLE SURGICAL AND IMPLANT-RELATED DIFFICULTIES AT AN EARLY STAGE. BETWEEN FEBRUARY 1999 TO FEBRUARY 2000, A TOTAL OF 126 PATIENTS (70 MALE AND 56 FEMALE) WITH A MEAN AGE OF 46.9 YEARS (RANGE, 14-82 YEARS) WERE INCLUDED IN THE STUDY. 70 PATIENTS (61% MEN, 39% WOMEN, AVERAGE AGE 43.1 YEARS) WERE SURGICALLY TREATED FOR RECENT FRACTURES OF THE THORACIC AND LUMBAR SPINE. 26 CASES (35% MEN, 65% WOMEN, AVERAGE AGE 60.7 YEARS) WERE ASSOCIATED WITH A TUMOR OR METASTASIS OF THE SPINE. THE PATIENTS WERE TREATED WITH SYNEX AND THE USS INTERNAL FIXATOR (79/85) WAS MOST FREQUENTLY USED FOR DORSAL IMPLANTS AND VENTROFIX (48/58) FOR VENTRAL IMPLANTS. THE MEAN DURATION OF FOLLOW-UP WAS UNKNOWN. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT INCOMPLETE PARAPLEGIA, WHICH GRADUALLY DISAPPEARED OVER TIME, OCCURRED DUE TO EXCESSIVE DISTRACTION DURING THE EXPANSION OF THE SYNEXTM IMPLANT. WHEN INSERTING SYNEXTM, THE SPACER PROVED TO BE PARTIALLY ROTATIONALLY UNSTABLE (3 TIMES) WITHIN THE HOLDING INSTRUMENTATION. MOUNTING A VENTROFIXTM AFTER POSITIONING THE SYNEX IMPLANT CAUSED PROBLEMS IN ONE CASE. ATTEMPTS TO COMPRESS SYNEX AFTER IT WAS EXPANDED IN SITU USING THE DISCONNECTION INSTRUMENTS PROVED TO BE DIFFICULT IN SEVERAL CASES (4 TIMES), ESPECIALLY WHEN SYNEX WAS EXPANDED IN A TILTED POSITION. SUBSIDENCE INTO THE END PLATES OF THE ADJACENT VERTEBRAL BODIES AFTER MOBILIZATION WAS OBSERVED IN INDIVIDUAL CASES WITH KNOWN LOW BONE DENSITY. IN SEVERAL CASES THE BASE OF THE TEETH WAS DESCRIBED AS TOO WIDE, CAUSING THE CLAMPS NOT TO MAKE CONTACT WITH THE END PLATES (5 TIMES). THIS REPORT CAPTURES THE FOLLOWING ADVERSE EVENTS: WHEN INSERTING SYNEXTM, THE SPACER PROVED TO BE PARTIALLY ROTATIONALLY UNSTABLE (3 TIMES) WITHIN THE HOLDING INSTRUMENTATION. ATTEMPTS TO COMPRESS SYNEX AFTER IT WAS EXPANDED IN SITU USING THE DISCONNECTION INSTRUMENTS PROVED TO BE DIFFICULT IN SEVERAL CASES (4 TIMES), ESPECIALLY WHEN SYNEX WAS EXPANDED IN A TILTED POSITION. IN SEVERAL CASES THE BASE OF THE TEETH WERE DESCRIBED AS TOO WIDE, CAUSING THE CLAMPS NOT TO MAKE CONTACT WITH THE END PLATES (5 TIMES) CONSEQUENTLY, THESE PINS ARE TO BE SHORTENED SLIGHTLY IN THE NEXT IMPLANT ¿GENERATION¿. THIS REPORT IS FOR A SYNTHES SYNEX IMPLANT. THIS IS REPORT 4 OF 4 FOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448212 SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1