BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RONG ANGL-UPWARDS W/4 L330

    MDR report key: 3181773 · Received June 21, 2013

    Report

    Report Number
    8030965-2013-03742
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    August 5, 2011
    Report Date
    September 20, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. THE DEVICE WAS NOT RETURNED FOR INSPECTION AND HENCE THE EVENT WAS NOT CONFIRMED. THE 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. WHILE NO PRODUCT FAULT COULD BE DETECTED, THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW BROKE. 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
    282202 RONG ANGL-UPWARDS W/4 L330 HTX SYNTHES GMBH T929902

    Patients

    Seq Age Sex Outcome Treatment
    1