BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRANIOFACIAL RIGID FIXATION SYSTEM 1.2MM SCREW

    MDR report key: 4231774 · Received October 15, 2014

    Report

    Report Number
    2027754-2014-00012
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 4, 2014
    Report Date
    October 15, 2014
    Manufacturer
    OSTEOMED
    Product Code
    DZL
    PMA / PMN Number
    K911936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INITIAL REVIEW OF THE COMPLAINT, THE DETAILS OF THE EVENT, AS COMMUNICATED ON (B)(6) 2014, DID NOT NECESSITATE AN MDR. HOWEVER, BASED UPON OUR REVIEW OF THE INFO RECEIVED ON 10/14/2014, AN MDR IS REQUIRED. THEREFORE, THE COMPLAINT FILE HAS BEEN DOCUMENTED WITH THE MDR DECISION CHANGE AND MDR FILING. THE DEVICE HAS BEEN SHIPPED BACK TO OSTEOMED, BUT HAS NOT BEEN RECEIVED. UPON RECEIPT, THE DEVICE WILL BE EVALUATED.

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION SHOWS THAT THE SCREW WAS IMPLANTED PAST OSTEOGENESIS. PER THE IFU, THE CFX SCREWS ARE INTENDED FOR TEMPORARY FIXATION ONLY UNTIL OSTEOGENESIS OCCURS. THE SCREW WAS IMPLANTED FOR A PERIOD OF NINE (9) MONTHS BEFORE REMOVAL. THE EVALUATION OF THE RETURNED SCREW SUGGESTS THAT THE DAMAGE OBSERVED WAS DUE TO REMOVAL BY BENDING AND TORQUING OF THE SCREW. THE REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES. THE REVIEW OF COMPLAINTS AND NCRS DID NOT IDENTIFY A SIMILARLY RELATED ISSUE WITHIN THE LAST YEAR. NO FURTHER ACTION REQUIRED. THIS ISSUE WILL BE MONITORED THROUGH INTERNAL TRENDING. QA NOTE: DURING AN AUDIT OF MDR SUBMISSIONS, WE IDENTIFIED THAT THE FOLLOW UP FOR THIS REPORT WAS INADVERTENTLY NOT SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, OSTEOMED WAS NOTIFIED OF A COMPLAINT AGAINST P/N 204-1210. PER THE INITIAL COMPLAINT INFO, THE MINI SCREW 1.2MM WAS BROKEN DURING REMOVAL, AFTER IMPLANTATION. PER ADD'L INFO RECEIVED ON (B)(6) 2014, THE SCREW WAS BEING REMOVED TO PREPARE FOR THE IMPLANT. IN ORDER TO REMOVE THE BROKEN SCREW, THE PHYSICIAN DUG UP THE BONE AND FILLED THE VOID WITH BONE SUBSTITUTE. THE PT RECEIVED HIS IMPLANT ON (B)(6) 2014 AND IS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652685 CRANIOFACIAL RIGID FIXATION SYSTEM 1.2MM SCREW 1.2MM SCREW DZL OSTEOMED 1047390

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization