BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIX DISTRACTOR RACK

    MDR report key: 3041892 · Received April 8, 2013

    Report

    Report Number
    8030965-2013-10728
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    March 27, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. NO IRREGULARITIES WERE FOUND DURING THE DEVICE HISTORY RECORD REVIEW. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT THE THUMBSCREW ASSEMBLY AND SECURING SCREW WERE MISSING FROM THE DISTRACTOR. IT IS NOT POSSIBLE TO CONDUCT A FULL INVESTIGATION TO ESTABLISH THE EXACT CAUSE OF WHY THE THUMBSCREW ASSEMBLY WAS MISSING BECAUSE ALL THE PARTS WERE NOT RETURNED. THEREFORE, WE CONCLUDE THIS COMPLAINT TO BE INDETERMINATE.

    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. ACTUAL EVENT DATE NOT KNOWN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISTRACTOR WAS MISSING A PIECE. IT IS NOT KNOWN HOW OR WHEN IT GOT BROKEN. IT WAS NOT USED IN A PROCEDURE AND THERE WAS NO KNOWN PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142953 MATRIX DISTRACTOR RACK LXH SYNTHES GMBH T940195

    Patients

    Seq Age Sex Outcome Treatment
    1