BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3921293 · Received July 9, 2014

    Report

    Report Number
    2520274-2014-12286
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    March 26, 2014
    Report Date
    June 9, 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 WAS USED FOR TREATMENT NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN TITANIUM VOLAR LOCKING 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. 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 ARTICLE: OUTCOMES AND COMPLICATIONS OF FRACTURES OF DISTAL RADIUS (AO TYPE B AND C): VOLAR PLATING VERSUS NONOPERATIVE TREATMENT. THIS PROSPECTIVE STUDY COMPARES OUTCOMES AND COMPLICATIONS OF AO TYPE B AND C FRACTURES OF THE DISTAL RADIUS TREATED WITH VOLAR LOCKED PLATING AND NONOPERATIVE METHODS. FROM AUGUST 2009 TO DECEMBER 2010, 64 PATIENTS WITH FRACTURES OF THE DISTAL RADIUS (AO TYPE B AND C) WERE INCLUDED IN THIS STUDY, ACCORDING TO INCLUSION CRITERIA, AND WERE ALLOCATED TO THE VOLAR PLATING GROUP OR NONOPERATIVE GROUP BY ALTERNATE RANDOMIZATION: 32 PATIENTS WITH ODD NUMBERS WENT INTO THE NONOPERATIVE GROUP AND THE OTHER 32 WITH EVEN NUMBERS WENT INTO THE VOLAR PLATING GROUP. THE AVERAGE AGE IN THE NONOPERATIVE GROUP WAS 52.39 ± 9.05 YEARS, AND IN PLATING GROUP WAS 48.10 ± 10.30 YEARS. THOSE IN THE VOLAR PLATING GROUP WERE MANAGED BY OPEN REDUCTION AND FIXATION WITH A VOLAR LOCKED PLATE. PREOPERATIVE AND POSTOPERATIVE SERIAL CLINICO-RADIOLOGICAL FOLLOW-UP WAS DONE. THE PURPOSE OF THIS STUDY WAS TO COMPARE THE CLINICORADIOLOGICAL OUTCOMES IN TERMS OF RANGE OF MOVEMENT, GRIP STRENGTH, WRIST PAIN, DEFORMITY, OSTEOARTHRITIS, COMPLICATIONS AND RADIOLOGICAL PARAMETERS. IN THE PLATING GROUP, PATIENTS WERE TREATED WITH OPEN REDUCTION AND INTERNAL FIXATION WITH TITANIUM VOLAR LOCKING PLATES (SYNTHES). OPERATIONS WERE PERFORMED BY THE SAME SURGEON IN ALL CASES, AND THE IMPLANT USED WAS OF THE SAME MANUFACTURER (SYNTHES). ARTICULAR STEP-OFF (C 2 MM) WAS PRESENT IN 13 PATIENTS IN THE NONOPERATIVE GROUP AND 4 PATIENTS IN THE PLATING GROUP AT POST REDUCTION/POSTOPERATIVE 1 WEEK. OSTEOARTHRITIC CHANGES (GRADE 1) WERE PRESENT IN 16 PATIENTS IN THE NONOPERATIVE GROUP AND IN 5 PATIENTS IN THE PLATING GROUP AT FINAL FOLLOW-UP (24 MONTHS). MOST CLINICAL AND RADIOLOGICAL PARAMETERS IMPROVED WITH FIXATION WITH THE NOTABLE EXCEPTION OF RADIAL, ULNAR DEVIATION AND VARIANCE NOT IMPROVING SIGNIFICANTLY. THERE WERE 2 CASES OF FLEXOR POLLICIS LONGUS TENDINITIS IN THE PLATING GROUP. IN THE VOLAR PLATING GROUP, 1 CASE HAD PREOPERATIVE MEDIAN NERVE SYMPTOMS AND CARPAL TUNNEL RELEASE WAS DONE DURING PLATING. FINAL NEUROLOGIC EXAMINATION SHOWED COMPLETE RESOLUTION AT THE LAST FOLLOW-UP. THE IMPROVED CLINICO-RADIOLOGICAL OUTCOME ACHIEVED WITH OPERATIVE TREATMENT (VOLAR PLATING) WAS DUE TO INTRAOPERATIVE REDUCTION OF DISTAL RADIAL ANATOMY, STABILIZATION OF THE REDUCTION WITH A VOLAR LOCKING PLATE, EXTENSIVE FOLLOW-UP, AND AN EARLY PHYSIOTHERAPY REGIMEN THROUGHOUT THE STUDY PERIOD. THIS IS REPORT 1 OF 1 FOR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401708 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention