BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3915415 · Received July 7, 2014

    Report

    Report Number
    2520274-2014-12334
    Event Type
    Injury
    Date Received
    July 7, 2014
    Date of Event
    July 1, 2012
    Report Date
    June 10, 2014
    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

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN DISTAL RADIUS LOCKING T PLATE/UNKNOWN QUANTITY /UNKNOWN LOT. 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. 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 JOURNAL ABSTRACT, ¿TREATMENT FOR UNSTABLE DISTAL CLAVICLE FRACTURES (NEER 2) WITH LOCKING T-PLATE AND ADDITIONAL PDS CERCLAGE" (2012, JULY, 1). MARTETSCHLAGER, F., ET. AL. KNEE SURGERY SPORTS TRAUMATOLOGY ARTHROSCOPY, 21:1189-1194. THIRTY OUT OF 37 CONSECUTIVE PATIENTS WHO SUSTAINED AN UNSTABLE FRACTURE OF THE DISTAL CLAVICLE TREATED BY LOCKING T-PLATE FIXATION AND ADDITIONAL PDS CERCLAGE BETWEEN 01/2007 AND 01/2010 WERE INCLUDED IN THE STUDY. THE GROUP CONSISTED OF 10 WOMEN AND 20 MEN, WITH A MEDIAN AGE OF 36 YEARS (RANGE 16¿68) AT THE TIME OF SURGERY. THE FRACTURE WAS THEN REDUCED UNDER DIRECT VISUALIZATION AND FLUOROSCOPIC CONTROL. ONCE REDUCTION WAS OBTAINED, A DISTAL RADIUS LOCKING T-PLATE (SYNTHES, (B)(4)) WAS INSERTED AND FIXED TO THE DISTAL FRAGMENT WITH AT LEAST 3 LOCKING SCREWS. IN 12 PATIENTS, THE IMPLANT WAS REMOVED BECAUSE IT WAS REGARDED AS DISTURBING, WITH MILD PAIN OVER THE IMPLANT, AFTER A MEAN OF 9.5 MONTHS, WHICH RESOLVED THIS PROBLEM IN ALL CASES. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR UNKNOWN DISTAL RADIUS LOCKING T PLATES. THIS REPORT IS FOR 1 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394727 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention