BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4606003 · Received March 16, 2015

    Report

    Report Number
    2520274-2015-11793
    Event Type
    Injury
    Date Received
    March 16, 2015
    Report Date
    February 23, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. JOHNSTON, P.S., ET.AL. (2014). "FIXATION OF UNSTABLE TYPE II CLAVICLE FRACTURES WITH DISTAL CLAVICLE PLATE AND SUTURE BUTTON." J ORTHOP TRAUMA (NOVEMBER 2014; 28(11). THIS REPORT IS FOR UNKNOWN CLAVICLE PLATE, UNKNOWN QUANTITY, UNKNOWN LOT. (B)(4) REVISION SURGERY. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING ARTICLE, JOHNSTON, P.S., ET.AL. (2014). "FIXATION OF UNSTABLE TYPE II CLAVICLE FRACTURES WITH DISTAL CLAVICLE PLATE AND SUTURE BUTTON." J ORTHOP TRAUMA (NOVEMBER 2014; 28(11). SIX PATIENTS WITH 6 UNSTABLE TYPE II DISTAL CLAVICLE FRACTURES WERE EVALUATED FROM 2010 TO 2012. ALL WERE MEN THAT SUSTAINED A TRAUMATIC INJURY INCLUDING A FALL FROM HEIGHT, BICYCLE ACCIDENT, RUGBY INJURY, SKIING INJURY, AND MOTOR VEHICLE COLLISION. IN ADDITION, ALL PATIENTS WERE FOUND TO HAVE A CLINICALLY NORMAL NEUROVASCULAR EXAMINATION. ALL PATIENTS WERE CONSIDERED TO BE AT A HIGH RISK FOR POTENTIAL NONUNION. WHEN REDUCED, A FRACTURE-SPECIFIC DISTAL CLAVICLE PLATE (ACUMED, HILLSBORO, OR, OR DEPUY SYNTHES, (B)(4)) WAS PLACED IN A POSITION THAT ALLOWED A SCREW HOLE TO OVERLIE THE CORACOID FOR PLACEMENT OF THE SUTURE-BUTTON DEVICE. MALE, IMPLANTED WITH EITHER DEPUY SYNTHES OR COMPETITOR FRACTURE-SPECIFIC DISTAL CLAVICLE PLATE, UNDERWENT SURGERY FOR IMPLANT REMOVAL DUE TO PAINFUL IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN CLAVICLE PLATE AND REFERS TO PAIN AND REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178087 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention