BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4298812 · Received December 4, 2014

    Report

    Report Number
    2520274-2014-15016
    Event Type
    Injury
    Date Received
    December 4, 2014
    Report Date
    November 12, 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

    THIS REPORT IS FOR AN UNKNOWN LOCKING PLATE/UNKNOWN QUANTITY/UNKNOWN LOT. 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, "ANTERIOR PELVIC EXTERNAL FIXATOR VERSUS SUBCUTANEOUS INTERNAL FIXATOR IN THE TREATMENT OF ANTERIOR RING PELVIC FRACTURES" COLE, P., GAUGER, E., ANAVIAN, J., LY, T., MORGAN, R., AND HEDDINGS, A. (2012). J ORTHOP TRAUMA, 26:5, 269-277. THE AUTHORS CONDUCTED A STUDY FROM DECEMBER 2005 TO NOVEMBER 2009 IN WHICH 48 PATIENTS WITH UNSTABLE PELVIC RING INJURIES WERE TREATED WITH ANTERIOR PELVIC EXTERNAL FIXATOR (APEF) OR ANTERIOR PELVIC INTERNAL FIXATOR (APIF). THERE WERE 24 PATIENTS IN EACH GROUP. THE APEF GROUP WAS TREATED WITH A 2-PIN AND 2-BAR CONSTRUCT (SYNTHES, (B)(4)). FOR THE APEF, THERE WERE FOUR INSTANCES OF LOSS OF FIXATION NOTED, EITHER FROM PINS OR PULLOUT FROM THE ILIUM. THERE WERE 5 EPISODES OF PAIN NOTED AT PINSITE UNTIL FIXATOR WAS REMOVED. THE APIF GROUP WAS TREATED WITH A 14-HOLE, 16-HOLE OR 18-HOLE LOW-PROFILE, 3.5 MM LOCKING PELVIC RECONSTRUCTION PLATEA (SYNTHES). ONE PATIENT EXPERIENCED RAMII NONUNIONS, AND WAS NOTED TO CARRY A DIAGNOSIS OF EHLERS DANLOS SYNDROME. ONE PATIENT WAS NOTED TO HAVE EXPIRED BEFORE THE REMOVAL OF THE APIF. THIS REPORT IS 1 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN LOCKING PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784804 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention