BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4609632 · Received March 17, 2015

    Report

    Report Number
    2520274-2015-11784
    Event Type
    Injury
    Date Received
    March 17, 2015
    Report Date
    February 22, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. BOSTROM, H,. VON HEIDEKEN, J., UNE-LARSSON, V. AND EKKELUND, A. (2010). "SURGICAL TREATMENT OF THE CHRONIC ACROMIOCLAVICULAR DISLOCATIONS: A COMPARATIVE STUDY OF WEAVER-DUNN AUGMENTED WITH PDS-BRAID OR HOOK PLATE" JOURNAL OF SHOULDER AND ELBOW SURGERY, 19, 1040-1048. THIS REPORT IS FOR UNKNOWN STAINLESS STEEL HOOK PLATE/UNKNOWN QUANTITY/UNKNOWN LOT. THIS INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NI DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE BOSTROM, H,. VON HEIDEKEN, J., UNE-LARSSON, V. AND EKKELUND, A. (2010). "SURGICAL TREATMENT OF THE CHRONIC ACROMIOCLAVICULAR DISLOCATIONS: A COMPARATIVE STUDY OF WEAVER-DUNN AUGMENTED WITH PDS-BRAID OR HOOK PLATE" JOURNAL OF SHOULDER AND ELBOW SURGERY, 19, 1040-1048. (B)(6) ARTICLE. THE OBJECTIVE WAS TO EVALUATE THE WEAVER-DUNN PROCEDURE (W-D) FOR CHRONIC ACROMIOCLAVICULAR JOINT DISLOCATION AUGMENTED WITH TEMPORARY HOOK PLATE OR BRAIDED POLYDIOXANONE (PDS) LOOP SUTURE. IT WAS RETROSPECTIVE COMPARATIVE STUDY FOR PATIENTS TREATED WITH CHRONIC ACROMIOCLAVICULAR JOINT DISLOCATIONS FROM 1995-2006; 47 OUT OF 52 INCLUDED PATIENTS WERE RE-EXAMINED. 23 PATIENTS WERE OPERATED WITH W-D AUGMENTED WITH THE PDS BRAID AND 24 WITH W-D AND A TEMPORARY HOOK PLATE. THIRTY-SIX WERE RE-EXAMINED AND HAD POST-OPERATIVE RADIOGRAPHS. ELEVEN PATIENTS WERE EVALUATED OVER THE PHONE. AN UNKNOWN NUMBER OF PATIENTS EXPERIENCED PAIN. ONE PATIENT EXPERIENCED PAIN AND DISLOCATED PLATE AND REVISION. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR UNKNOWN STAINLESS STEEL HOOK PLATE AND REFERS TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181542 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention