BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEOMED

    MDR report key: 9711550 · Received February 14, 2020

    Report

    Report Number
    2027754-2020-00002
    Event Type
    Malfunction
    Date Received
    February 14, 2020
    Date of Event
    December 15, 2019
    Report Date
    January 16, 2020
    Manufacturer
    OSTEOMED
    Product Code
    HRS
    UDI-DI
    00845694003742
    PMA / PMN Number
    K911936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SHORT, LEFT, RECONSTRUCTION PLATE, P/N 214-0102, WAS IMPLANTED ON (B)(6) 2019. SLIGHTLY MORE THAN TWO MONTHS POST-OP, ON (B)(6) 2019, THE PLATE WAS FOUND TO BE BROKEN. A COPY OF THE X-RAY WAS PROVIDED. AS OF (B)(6) 2020, THE PLATE HAD NOT BEEN EXPLANTED. SEVERAL SURGICAL RELATED QUESTIONS WERE SENT FOR THE SURGEON TO ANSWER, BUT NO RESPONSE HAS BEEN RECEIVED. THE POSSIBLE CAUSES THAT COULD HAVE CONTRIBUTED TO THE POST-OP PLATE BREAKAGE INCLUDE: A NON-COMPLIANT PATIENT, A SECONDARY TRAUMA TO THE MANDIBLE, POSSIBLE SCREW FAILURE (NON-OSTEOMED SCREWS), INADEQUATE PLATE DESIGN SPECIFICATIONS, IMPROPER PLATE SIZE SELECTION, NO OR SLOW OSTEOGENESIS, EXCESSIVE BENDING OF THE PLATE PRE-IMPLANTATION, INSUFFICIENT BONE, POOR BONE QUALITY, AND THAT THE PLATE EXPERIENCED/ENDURED EXCESSIVE ABNORMAL FUNCTIONAL STRESSES. 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. THIS IS THE ONLY COMPLAINT FOR THIS ISSUE, "BROKEN PLATE - POST-OP", DISCOVERED IN A TWO-YEAR REVIEW OF THE COMPLAINT DATABASE FOR MANDIBLE RECONSTRUCTION PLATES. THIS PLATE IS A PART OF THE M3-M4-CFX SYSTEM. THE RISK DOCUMENT IS FMEA-0603, REVISION W. THE RISK OF A NON-UNION OF BONE, A MISALIGNMENT OF BONE, OR A COLLAPSE OF THE FRACTURE, DUE TO A PLATE BREAKING IN-VIVO IS COVERED IN THE FMEA. THE RISK HAS A SEVERITY RATING OF 3. PER SOP-ENG-006, A RATING OF 3 INDICATES A "SERIOUS" SEVERITY LEVEL (RESULTS IN INJURY OR IMPAIRMENT REQUIRING PROFESSIONAL MEDICAL INTERVENTION). THE PROBABILITY RATING IS A 1, WHICH PER SOP-ENG-006 IS A "LOW" (UNLIKELY TO HAPPEN, RARE, REMOTE). THE FINAL PREDICTED RISK LEVEL IS "LOW". THE M3/M4/CFX INSTRUCTIONS FOR USE (IFU) IS P/N 030-1552, REVISION AD. THE IFU LISTS CONTRAINDICATIONS SUCH AS USING THIS SYSTEM IN A PATIENT WHO MIGHT IGNORE THE LIMITATIONS OF RIGID FIXATION PLATE AND SCREW IMPLANTS AND/OR IN PATIENTS WHERE THERE IS INSUFFICIENT BONE OR POOR BONE QUALITY. THE IFU ALSO WARNS ABOUT USING AN UNDERSIZED PLATE OR SCREW IN AREAS OF HIGH FUNCTIONAL STRESSES (SUCH AS THE MANDIBLE) WHICH COULD LEAD TO PLATE FAILURE. IT ALSO STATES THAT MULTIPLE BENDING MAY WEAKEN THE PLATE AND COULD RESULT IN PLATE FAILURE. THE IFU STATES THAT THE OSTEOMED FIXATION SYSTEM PLATES ARE NOT INTENDED TO ENDURE EXCESSIVE ABNORMAL FUNCTIONAL STRESSES. THIS PLATE IS INTENDED FOR TEMPORARY FIXATION ONLY UNTIL OSTEOGENESIS OCCURS. FINALLY, THE IFU STATES, "DEDICATED OSTEOMED PLATES, SCREWS, AND INSTRUMENTATION ARE REQUIRED FOR EACH SURGERY." THIS ISSUE WILL BE MONITORED THROUGH ROUTINE TRENDING.

    Description of Event or Problem · 1

    ON (B)(6) 2020 OSTEOMED WAS NOTIFIED OF A PATIENT DIAGNOSED ODONTOGENIC KERATOCYTES ANGULUS MANDIBULA SINISTRA, OPERATED WITH SEGMENTAL RESECTION AND USED OSTEOMED PLATE AND 7 PCS OF OTHER BRAND SCREW (OSTEONIC - MADE IN (B)(6). TWO (2) MONTH AFTER SURGERY (B)(6) 2019), OSTEOMED PLATE WAS FOUND TO BE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174995 OSTEOMED SHORT, LEFT, RECONSTRUCTION PLATES HRS OSTEOMED 214-0102 1038007 00845694003742

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR