BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4586664 · Received March 10, 2015

    Report

    Report Number
    2520274-2015-11412
    Event Type
    Malfunction
    Date Received
    March 10, 2015
    Report Date
    February 25, 2015
    Manufacturer
    DEPUY SYNTHES (USA)
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT AND NOT DIAGNOSIS. AUTHORS: MORALES DAVILA J., DOMINGO TREPAT A., RIOS MARTIN M., CARRENO DELGADO A., BALLESTEROS BETANCOURT J., GARCIA ELVIRA R., GARCIA TARRINO R., CAMACHO P., ZUMBADO A., PRAT FABREGAT S. SOURCE: MINERVA ORTOPEDICA E TRAUMATOLOGICA. 2013; 64(3):333-340. THIS REPORT IS FOR AN UNKNOWN SYNTHES PLATE. 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. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    AUTHORS: MORALES DAVILA J., DOMINGO TREPAT A., RIOS MARTIN M., CARRENO DELGADO A., BALLESTEROS BETANCOURT J., GARCIA ELVIRA R., GARCIA TARRINO R., CAMACHO P., ZUMBADO A., PRAT FABREGAT S. SOURCE: MINERVA ORTOPEDICA E TRAUMATOLOGICA. 2013; 64(3):333-340. DISTAL CLAVICLE FRACTURES ACCOUNT FOR 15% OF ALL CLAVICLE FRACTURES. NEER TYPE II LATERAL END FRACTURES ARE ASSOCIATED WITH NON-UNION RATES OF 30%. FURTHER, FIXATIONS BY WAY OF HOOK PLATES SEEM TO HAVE PROVED SUCCESSFUL. WE REPORT OUR EXPERIENCE USING THE HOOK PLATE IN THE TREATMENT OF DISTAL CLAVICLE FRACTURES. METHODS: TWENTY FOUR PATIENTS WITH DISTAL CLAVICLE FRACTURES WERE OPERATED ON AND HAD AN AO HOOK PLATE (SYNTHES) IMPLANTED. 20 MEN AND 4 WOMEN WERE RETROSPECTIVELY REVIEWED. THE AVERAGE AGE AT TIME OF SURGERY WAS 35 (RANGE 18-74). ALL THE PATIENTS PRESENTED WITH A NEER TYPE II DISTAL FRACTURE. THE AVERAGE FOLLOW-UP WAS 20 MONTHS (RANGE 10-26), AND THE PATIENTS WERE RADIOLOGICALLY AND CLINICALLY EVALUATED DURING THIS PERIOD OF TIME. THE CONSTANT-MURLEY SCORE WAS USED TO MEASURE SHOULDER MOVEMENT, STRENGTH AND PAIN. THE PATIENT'S ABILITY TO CARRY OUT HIS OR HER DAILY-LIFE ACTIVITIES WAS MEASURED WITH BOTH THE CONSTANT-MURLEY SCORE AND THE OXFORD TEST. RESULTS: TWENTY FOUR PATIENTS ACHIEVED CLINICAL AND RADIOLOGIC UNION AND ONE PATIENT SUFFERED FROM FAILURE OF FIXATION. ALL THE PLATES WERE REMOVED. (B)(4). PART 1 OF 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165047 PLATE, FIXATION, BONE HRS DEPUY SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1