BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MULTI VECTOR DISTRACTOR BODY

    MDR report key: 3003548 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-10423
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    May 25, 2011
    Report Date
    June 21, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    DZL
    PMA / PMN Number
    K981362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED SCRATCHES AND MINOR MARKS ON THE SURFACE. THE PRODUCT INVESTIGATION SHOWED ALL RELEVANT FEATURES FOR THIS COMPLAINT CAN NOT BE MEASURED, BECAUSE THE ASSEMBLY CANNOT BE DISASSEMBLED TO ACCESS THE BROKEN "WORM" WITHOUT DAMAGING THIS COMPONENT, THEREFORE THIS COMPLAINT IS INDETERMINATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANSVERSE ADJUSTMENT WITH THE DISTRACTOR BODY WHICH BEGAN ON (B)(6) 2011 AS THE SURGEON WAS COMING AWAY FROM THE PATIENT A HEX SCREW BROKE OFF THE DISTRACTOR BODY ON (B)(6) 2011. THE SURGEON SELECTED ANOTHER DISTRACTOR BODY TO COMPLETE THE PROCEDURE WITH NO ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86227 TI MULTI VECTOR DISTRACTOR BODY DZL SYNTHES GMBH 6409304

    Patients

    Seq Age Sex Outcome Treatment
    1