BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEOMED SBF SYSTEM

    MDR report key: 6956763 · Received October 17, 2017

    Report

    Report Number
    2027754-2017-00010
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Date of Event
    September 22, 2017
    Report Date
    December 19, 2017
    Manufacturer
    OSTEOMED
    Product Code
    DZL
    PMA / PMN Number
    K911936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT ROOT CAUSE FOR THE BROKEN 10-HOLE STRAIGHT PLATE, P/N 210-0032, COULD NOT BE DETERMINED. HOWEVER, BASED UPON THIS INVESTIGATION, IT APPEARS TO BE RELATED TO THE FACT THAT OSTEOGENESIS DID NOT OCCUR IN THE FIRST 5 MONTHS POST-SURGERY. THIS PLATE IS DESIGNED FOR TEMPORARY BONE FIXATION, APPROXIMATELY 7-8 WEEKS, UNTIL OSTEOGENESIS (BONE GROWTH FIXATING THE BONE) OCCURS. THIS LACK OF BONE GROWTH PLACED AN EXTENDED STRESS UPON THE PLATE FOR MONTHS BEYOND EXPECTATIONS. ANOTHER CONTRIBUTOR OF THIS ISSUE IS RELATED TO THE FACT THAT THE PLATE EXPERIENCED AN EXCESSIVE, SHORT TERM, ABNORMAL FUNCTIONAL STRESS INVOLVING A JAW-CLENCHING INCIDENT, WHICH IMMEDIATELY CAUSED THE PLATE TO BREAK INTO MULTIPLE PIECES. THIS IS CONSIDERED A NON-COMPLIANT PATIENT EVENT, EVEN THOUGH THE INCIDENT WAS NOT INTENDED, BUT WAS ADMITTED TO BY THE PATIENT. THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, A REVIEW OF THE DHR COULD NOT BE PERFORMED. A TWO-YEAR REVIEW OF CAPAS, NCRS, AND COMPLAINTS DID NOT IDENTIFY ANY INTERNAL INVESTIGATIONS OR NON-CONFORMANCES FOR THIS DEVICE. A REVIEW OF THE LABELING, THE CFX IFU, WARNED THE USER THAT THE PLATES ARE INTENDED FOR TEMPORARY FIXATION UNTIL OSTEOGENESIS OCCURS, WHICH DID NOT OCCUR IN THIS INSTANCE. THE LABELING ALSO WARNED THE USER ABOUT EXCESSIVE ABNORMAL FUNCTIONAL STRESSES, WHICH THE PLATE EXPERIENCED. THE RISK LEVEL ASSOCIATED WITH THIS INCIDENT IS LOW. THIS ISSUE WILL BE MONITORED THROUGH ROUTINE TRENDING.

    Description of Event or Problem · 1

    ON (B)(6) 2017, OSTEOMED WAS NOTIFIED THAT THE PLATES BROKE AFTER A MEAL.

    Description of Event or Problem · 1

    ON (B)(4) 2017, OSTEOMED WAS NOTIFIED THAT THE PLATES BROKE AFTER A MEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733548 OSTEOMED SBF SYSTEM 10 HOLE STRAIGHT PLATE DZL OSTEOMED UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| R