BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTREMILOCK ANKLE PLATING SYSTEM

    MDR report key: 8646368 · Received May 28, 2019

    Report

    Report Number
    2027754-2019-00008
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Date of Event
    April 24, 2019
    Report Date
    May 28, 2019
    Manufacturer
    OSTEOMED
    Product Code
    HRS
    UDI-DI
    00845694049689
    PMA / PMN Number
    K133691
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED 8-HOLE, 1/3 TUBULAR, ANKLE PLATE BROKE POST-OPERATIVELY. THE POSSIBILITIES THAT MIGHT HAVE CAUSED A BREAK POST-OPERATIVELY INCLUDE: EXCESSIVE BENDING OF THE PLATE PRE-OP, NON-UNION OF THE FRACTURE THAT PLACED ABNORMAL, LONG-TERM STRESS UPON THE PLATE, A NON-COMPLIANT PATIENT, POOR BONE QUALITY, DESIGN FLAW, MANUFACTURING FLAW, AND SECONDARY TRAUMA TO THE SURGICAL SITE. DUE TO LIMITED INFORMATION, THE EXACT ROOT CAUSE IS UNKNOWN. REVIEW OF THE DHR DID NOT IDENTIFY ANY NON-CONFORMANCES ASSOCIATED WITH LOT RELEASE. A TWO-YEAR REVIEW DID NOT IDENTIFY ANY CAPAS OR NCRS RELATED TO THIS IMPLANT FAMILY. THIS IS THE ONLY COMPLAINT FOR THIS ISSUE WITHIN THE LAST TWO (2) YEARS. THIS PLATE IS A PART OF THE EXTREMILOCK ANKLE PLATING SYSTEM (E-APS). THE E-APS RISK DOCUMENT INCLUDES AN ASSESSMENT OF THIS FAILURE MODE. THE RISK OF A NON-UNION (PRESUMED IN THIS CASE) DUE TO A BROKEN PLATEHAS A PREDICTED SEVERITY RATING OF 3. PER THE RISK MANAGEMENT PROCEDURE, A RATING OF 3 INDICATES A "SERIOUS" SEVERITY LEVEL (RESULTS IN INJURY OR IMPAIRMENT REQUIRING PROFESSIONAL MEDICAL INTERVENTION). DEPENDING ON THE POSSIBLE CAUSE, THE FINAL PREDICTED RISK LEVEL IS EITHER A "LOW" OR A "MEDIUM". THE E-APS INSTRUCTIONS FOR USE (IFU) OUTLINES SEVERAL CONTRAINDICATIONS, SUCH AS PATIENTS WITH CERTAIN METABOLIC DISEASES, OR INSUFFICIENT BONE OR POOR BONE QUALITY, OR DISORDERS THAT WOULD CAUSE THE PATIENT TO IGNORE THE PHYSICIAN'S PRE- AND /OR POST-OPERATIVE INSTRUCTIONS AND/OR THE LIMITATIONS OF INTERNAL RIGID FIXATION IMPLANTS. THE IFU HAS MULTIPLE USER WARNINGS SUCH AS PATIENTS MUST HAVE SUFFICIENT BONE QUALITY TO SUSTAIN EFFECTIVENESS AND BENEFITS OF RIGID FIXATION, USING UNDERSIZED IMPLANTS IN AREAS OF HIGH FUNCTIONAL STRESS MAY LEAD TO IMPLANT FRACTURE AND FAILURE, AND BENDING THE PLATE EXCESSIVELY MULTIPLE TIMES MAY WEAKEN THE PLATE AND COULD RESULT IN IMPLANT FAILURE. THE IFU ALSO STATES THE E-APS IMPLANTS ARE NOT INTENDED TO ENDURE EXCESSIVE ABNORMAL FUNCTIONAL STRESSES, THAT THEY ARE INTENDED FOR TEMPORARY FIXATION ONLY UNTIL OSTEOGENESIS OCCURS, AND THAT POST-OPERATIVE INSTRUCTIONS SHOULD BE GIVEN TO THE PATIENT BY THE SURGEON, INCLUDING 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

    THE PATIENT HAD SURGERY PREVIOUSLY FOR AN ANKLE FRACTURE THAT IS COMMONLY CORRECTED BY THE USE OF THE 1/3 TUBULAR PLATE AND SCREWS. IMPLANTS AND SURGERY WENT WELL. THE PATIENT REVISITED WITH THE PHYSICIAN AND FOUND THAT THE PLATE WAS BROKEN POST-OP. ON (B)(6) 2019, THE PHYSICIAN PERFORMED A HARDWARE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438157 EXTREMILOCK ANKLE PLATING SYSTEM 7 HOLE 1/3 TUBULAR PLATE HRS OSTEOMED 1126014 00845694049689

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention