BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADJUSTABLE CERVICAL DISTRACTOR-LEFT

    MDR report key: 3062946 · Received April 17, 2013

    Report

    Report Number
    8030965-2013-10941
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE VISUAL PRODUCT EVALUATION CONFIRMED THAT THE DISTRACTION PIN TUBE HAD FRACTURED OFF OF THE DISTRACTOR ON THE MALE END OF THE JOINT. SOME EVIDENCE OF USE CAN BE SEEN ON THE TRANSLATING PARTS. THE MALE PORTION OF THE HINGE WAS MEASURE TO BE 3.02MM WHICH IS WITHIN DESIGN SPECIFICATION. THE MANUFACTURING EVALUATION DETERMINED THE DISTRACTOR CORRESPONDS TO THE DRAWING AND PROCESSES AT THE TIME OF MANUFACTURE. THE ARM SEIZED AT THE HINGE DUE LACK OF MAINTENANCE, TOO MUCH FORCE WAS THEN REQUIRED TO MOVE THE ARM CAUSING IT TO BREAK. THE DISTRACTOR WAS WITHIN DESIGN SPECIFICATION AND NO IRREGULARITIES WERE FOUND. THE FORCE APPLIED TO THE DISTRACTOR ARM EXCEEDED THE LIMIT THAT IT COULD WITHSTAND; HOWEVER, THE DETAILS SURROUNDING THE USE OF THE DISTRACTOR THAT LED TO THIS FAILURE ARE UNCLEAR.

    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. (B)(4). PLACEHOLDER.

    Description of Event or Problem · 1

    DURING AN ANTERIOR CERVICAL DISCECTOMY PROCEDURE, THE LEVER ARM BROKE OFF. NOTHING WAS LEFT IN THE PATIENT. THE SURGEON USED ANOTHER TO COMPLETE THE PROCEDURE WITH NO ADVERSE EFFECT TO THE PATIENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166003 ADJUSTABLE CERVICAL DISTRACTOR-LEFT LXH SYNTHES GMBH T943524

    Patients

    Seq Age Sex Outcome Treatment
    1