BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3781067 · Received April 30, 2014

    Report

    Report Number
    2520274-2014-11134
    Event Type
    Injury
    Date Received
    April 30, 2014
    Report Date
    April 4, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PT AGE: AGE WAS REPORTED AS (B)(6). DATE OF EVENT: UNKNOWN. ADDITIONAL DEVICE INFO: THIS REPORT IS FOR 2 UNKNOWN PLATES/UNKNOWN LOTS. IMPLANT DATE: INITIAL PLATE IMPLANTED ON AN UNKNOWN DATE IN (B)(6) 2014, SECOND PLATE IMPLANTED ON (B)(6), 2014. EXPLANT DATE: DEVICES HAVE NOT BEEN EXPLANTED. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    IT IS REPORTED THAT AN AUTISTIC PATIENT EXPERIENCED IRRITATION RESULTING IN SCRATCHING AFTER HAVING TWO PLATES IMPLANTED. THE PATIENT HAD A FALL IN THE MIDDLE OF (B)(6) 2014 AND THE SURGEON IMPLANTED A LARGE FRAG STAINLESS STEEL PLATE ANTERIOR LATERAL FOR A BROKEN HUMERUS. THE PATIENT HAD A SECOND FALL A FEW WEEKS LATER AND SUSTAINED ANOTHER HUMERUS FRACTURE DISTAL TO THE INITIAL PLATE AND HAD A SECOND PLATE IMPLANTED POSTERIOR DISTAL TO THE FIRST PLATE ON (B)(6), 2014. THE PATIENT WAS NOTED AS HEALING WELL, BUT AFTER THE SECOND PLATE WAS IMPLANTED THE PATIENT COMPLAINED OF IRRITATION RESULTING IN SCRATCHING. THE EXACT DATE OF THE IRRITATION AND THE ONSET OF SCRATCHING ARE UNKNOWN. THE SURGERIES WERE COMPLETED SUCCESSFUL AND NO DELAY IN THE SURGICAL TIME HAS BEEN REPORTED. THE IMPLANTS HAVE NOT BEEN EXPLANTED. THIS REPORT IS FOR TWO UNKNOWN PLATES. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260514 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention