BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTREMILOCK ANKLE PLATING SYSTEM

    MDR report key: 7388966 · Received April 2, 2018

    Report

    Report Number
    2027754-2018-00011
    Event Type
    Malfunction
    Date Received
    April 2, 2018
    Date of Event
    March 6, 2018
    Report Date
    April 2, 2018
    Manufacturer
    OSTEOMED
    Product Code
    HRS
    PMA / PMN Number
    K133691
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXACT ROOT CAUSE OF WHY THE PLATE, A MEDIAL TIBIA ANKLE PLATE, P/N 336-4006, BROKE TWO MONTHS POST-IMPLANTATION COULD NOT BE DETERMINED. THERE ARE MULTIPLE POSSIBILITIES. SOME INCLUDE ALLOWING PATIENT TO BEAR WEIGHT PREMATURELY, THUS FORCING THE PLATE TO EXPERIENCE EXCESSIVE LOADS; EXCESSIVELY BENDING THE PLATE PRIOR TO IMPLANTATION; A POOR PLATE DESIGN OR MATERIAL; THE PATIENT EXPERIENCED AN UNREPORTED SECONDARY TRAUMA TO THE SAME ANKLE; OR THE PATIENT DID NOT FOLLOW THE SURGEON'S POST-OPERATIVE INSTRUCTIONS. THERE WAS NO LOT NUMBER PROVIDED; THEREFORE, NO REVIEW OF THE DHR WAS POSSIBLE. A TWO-YEAR REVIEW DID NOT IDENTIFY ANY CAPAS FOR THIS PLATE. A TWO-YEAR REVIEW DID NOT IDENTIFY ANY NCRS FOR THIS PLATE. A REVIEW IDENTIFIED THIS AS THE ONLY COMPLAINT FOR THIS PLATE IN THE PAST FOUR YEARS (THE LIFETIME OF THE PRODUCT). THE RISK OF A NON-UNION WITH A RELATED BROKEN PLATE IS COVERED IN THE EXTREMILOCK ANKLE PLATING SYSTEM (E-APS) RISK DOCUMENT, AND HAS AN OVERALL RISK RATING OF "MEDIUM". THE E-APS IFU WARNS THE USER OF THE POSSIBLE ROOT CAUSES SUCH AS USE OF UNDERSIZED IMPLANTS IN AREAS OF HIGH FUNCTIONAL STRESS, EXCESSIVE BENDING OF THE PLATE PRE-IMPLANTATION, AND EXPECTING THE PLATE SYSTEM TO ENDURE EXCESSIVE ABNORMAL FUNCTIONAL STRESSES. THE IFU ALSO ALERTS THE USER THAT THE E-APS IS INTENDED FOR TEMPORARY FIXATION ONLY UNTIL OSTEOGENESIS OCCUR, AND THAT THE SURGEON SHOULD PROVIDE POST-OPERATIVE INSTRUCTIONS TO THE PATIENT, INCLUDING ALERTING THE PATIENT OF THE POTENTIAL FOR SECONDARY INJURIES TO A SURGICAL SITE IF THE PATIENT IS NON-COMPLIANT. THIS ISSUE WILL BE MONITORED THROUGH ROUTINE TRENDING.

    Description of Event or Problem · 1

    ON 03/12/2018, OSTEOMED WAS NOTIFIED OF AN INCIDENT CONCERNING ONE OF OUR IMPLANT DEVICES. PER THE DISTRIBUTOR, THE SURGERY WAS PERFORMED IN (B)(6) 2018. THE PLATE WAS REMOVED ON (B)(6) 2018 AFTER BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234010 EXTREMILOCK ANKLE PLATING SYSTEM 6H TIBIA FRACTURE PLATE HRS OSTEOMED UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention