BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP® MEDIAL DISTAL HUMERUS PLATE 5 HOLES-RIGHT

    MDR report key: 2891895 · Received December 31, 2012

    Report

    Report Number
    8030965-2012-01726
    Event Type
    Injury
    Date Received
    December 31, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K033995
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PART/LOT NUMBER COMBINATION UNKNOWN AT SYNTHES (B)(4). THE CLOSED LOT NUMBER WE USED FOR THIS PART NUMBER IS 7944040, MAY BE THAT 8 AND 0 WERE INTERCHANGED. THEREFORE THE MANUFACTURING DOCUMENTS FOR LOT 7944040 WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH LATERAL AND MEDIAL PLATES ON DISTAL HUMERUS, OLECRANON OSTEOTOMY NAIL, AND SCREW CONSTRUCT ON (B)(6) 2012. IT IS REPORTED THAT PATIENT IS VERY PETITE AND HAD A DIFFICULT TIME HEALING. ON AN UNKNOWN DATE, APPROXIMATELY THE FIRST WEEK IN (B)(6) 2012, THE END CAP ON THE OSTEOTOMY WAS REMOVED DUE TO WOUND BREAKDOWN. THIS IS ADDRESSED IN A SEPARATE COMPLAINT. SURGEON CONTINUED TO MONITOR THE PATIENT, AND DECIDED TO REMOVE THE MEDIAL PLATE, THE PATIENT WAS FULLY HEALED. ON (B)(6) 2012 PATIENT RETURNED TO THE O.R. AND THE DISTAL HUMERUS PLATE AND SCREW CONSTRUCT WERE REMOVED. THE SURGEON NOTED THAT HE FELT THE HARDWARE WASN'T AT FAULT, THE SURGEON FELT IT WAS THE PATIENTS SMALL BODY TYPE. SURGEON ALSO NOTED THAT HE MAY HAVE PLACED THE PLATE A LITTLE DISTAL. THIS IS 1 OF 7 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM LCP® MEDIAL DISTAL HUMERUS PLATE 5 HOLES-RIGHT PLATE KTT SYNTHES GMBH 7944840

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention SCREWS