BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEBRAL BODY RETAINER

    MDR report key: 3143522 · Received June 3, 2013

    Report

    Report Number
    2520274-2013-03052
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    March 17, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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. THE DEVICE LISTED IN THIS REPORT IS 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. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. THE INVESTIGATION HAS SHOWN THAT ONE RETAINER ARM HAS SEPARATED FROM THE RETAINER BECAUSE THE DOWEL PIN HAS FALLEN OUT. THE MACROSCOPIC EXAMINATION HAS SHOWN THAT THE PIN WAS SUFFICIENTLY SECURED WITH FOUR SPOT WELDS. WE ARE UNABLE TO GIVE A CONCLUSIVE STATEMENT REGARDING A POSSIBLE FAILURE REASON. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. WE ARE UNABLE TO GIVE A CONCLUSIVE STATEMENT REGARDING A POSSIBLE FAILURE REASON AND THE COMPLAINT CONDITION IS DUE TO AN UNKNOWN CAUSE.

    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). DEVICE MANUFACTURE DATE: 06/02/2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DOWEL PIN ON THE RETAINER ARM IS MISSING. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242930 VERTEBRAL BODY RETAINER LXH SYNTHES GMBH T947867

    Patients

    Seq Age Sex Outcome Treatment
    1