BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4688392 · Received April 14, 2015

    Report

    Report Number
    2520274-2015-12609
    Event Type
    Malfunction
    Date Received
    April 14, 2015
    Report Date
    March 25, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DODDS, S.D., SAVE, A.V., AND YACOB, A. (2013), DORSAL SPANNING PLATE FIXATION FOR DISTAL RADIUS FRACTURES, TECH HAND SURG,17, 192¿198. THIS REPORT IS FOR AN UNKNOWN PLATE. 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. 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

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, DODDS, S.D., SAVE, A.V., AND YACOB, A. (2013), DORSAL SPANNING PLATE FIXATION FOR DISTAL RADIUS FRACTURES, TECH HAND SURG,17, 192¿198. THE AUTHORS DESCRIBED THE OPERATIVE TECHNIQUE TO PLACE A DORSAL SPANNING PLATE AND PROVIDE A RETROSPECTIVE REVIEW OF OUTCOMES IN POLYTRAUMA PATIENTS. SPANNING PLATE FIXATION (OR SPANNING EXTERNAL FIXATION) DESCRIBES CROSSING AN ARTICULATION (THE WRIST JOINT) WITH OR WITHOUT TRACTION, AND BRIDGING THE FRACTURE SITE. THE AUTHORS USED A SYNTHES COMBINATION LOCKING/NONLOCKING PLATE TO MAINTAIN DISTRACTION ACROSS THE REDUCED FRACTURE SITE. THE AUTHORS PERFORMED A RETROSPECTIVE REVIEW OF MULTITRAUMA PATIENTS TREATED WITH DORSAL SPANNING PLATE FIXATION OVER A 5-YEAR PERIOD FROM SEPTEMBER 2006 TO JUNE 2011. ONLY THOSE PATIENTS WHO RECEIVED A SPANNING PLATE FOR TREATMENT OF A DISTAL RADIUS FRACTURE AND HAD ALREADY UNDERGONE SURGERY FOR REMOVAL OF THE PLATE WERE INCLUDED. A TOTAL OF 25 PATIENTS WERE IDENTIFIED. THERE WERE 11 FEMALE PATIENTS AND 14 MALE PATIENTS, WITH A MEAN AGE OF 54.6 YEARS. THREE PATIENTS SUFFERED TRUE HARDWARE FATIGUE (BROKEN PLATE AT THE LEVEL OF THE RADIOCARPAL JOINT) WELL AFTER FRACTURE HEALING. THIS REPORT IS FOR AN UNKNOWN PLATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248953 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1