BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMF SCREW Ø2 L12 SST

    MDR report key: 3192531 · Received June 27, 2013

    Report

    Report Number
    2520274-2013-03751
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    December 27, 2011
    Report Date
    April 2, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    DZL
    PMA / PMN Number
    K010527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT PERFORMED BECAUSE NO LOT NUMBER WAS PROVIDED AND IT WAS NOT AVAILABLE ON THE RETURNED PRODUCT. THE EVALUATION REVEALED THAT NO DETAILED CLINICAL INFORMATION IS AVAILABLE. THE EVIDENCE SHOWS THERE WAS A TECHNICAL COMPLICATION DURING SURGERY. A MANUFACTURING RELATED CONDITION CAN BE EXCLUDED BECAUSE THE CRACKS MIGHT HAVE BEEN CREATED BY CONTINUOUS TENSION, ON WHICH THESE LEAF SPRINGS ARE SUBJECTED TO. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE TIME SURGERY, THE IMF SCREW WAS PUT ON THE MANDIBULAR BODY BUT BROKE. IT WAS REPLACED BY A NEW SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294374 IMF SCREW Ø2 L12 SST DZL SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1