BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3684456 · Received March 18, 2014

    Report

    Report Number
    2520274-2014-10313
    Event Type
    Malfunction
    Date Received
    March 18, 2014
    Report Date
    February 16, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. THIS REPORT IS FOR MULTIPLE REPORTABLE MALFUNCTIONS. ELEVEN (110 PATIENTS HAD GRADE 1 ANKLE ARTHROSIS AND 2 PATIENTS HAD GRADE 2 ANKLE ARTHROSIS. THE ARTICLE DID NOT INDICATE ANY DATE OF EVENT REPORTED AS THE YEAR 2010. MA, C.-H.ET ALL, STAGED EXTERNAL AND INTERNAL LOCKED PLATING FOR OPEN DISTAL TIBIAL FRACTURES. A RETROSPECTIVE STUDY OF 16 PATIENTS, ACTA ORTHOPAEDICA. 2010 JUN 03; 81 (3), PP. 382-386. PATIENTS WERE IMPLANTED WITH EITHER DISTAL TIBIAL METAPHYSEAL PLATES OR LISS (LESS INVASIVE STABILIZATION SYSTEM)-DISTAL FEMUR PLATES. IMPLANT DATE: DATE UNKNOWN. UNKNOWN IF DEVICE WAS EXPLANTED. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICES WERE RETURNED AND NO LOT NUMBERS OR PART NUMBERS WERE 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: STAGED EXTERNAL AND INTERNAL LOCKED PLATING FOR OPEN DISTAL TIBIAL FRACTURES. A RETROSPECTIVE STUDY OF 16 PATIENTS. BASED ON REPORTED SUCCESS WITH STAGED TREATMENT OF DISTAL TIBIAL FRACTURES, WE DESIGNED A 2-STAGE PROTOCOL INCLUDING EXTERNAL/INTERNAL LOCKED PLATING. WE RETROSPECTIVELY ASSESSED THE OUTCOME OF OPEN DISTAL TIBIAL FRACTURES TREATED ACCORDING TO THIS PROTOCOL. FROM (B)(6) 2006 THROUGH (B)(6) 2008, 16 PATIENTS WHO SUSTAINED OPEN DISTAL TIBIAL FRACTURES WERE TREATED BY A TWO STAGE PROTOCOL. THE FIRST STAGE CONSISTED OF LOW-PROFILE, LOCKED PLATES FOR TEMPORARY EXTERNAL FIXATION AFTER DEBRIDEMENT AND ANATOMIC REDUCTION, FOLLOWED BY SOFT TISSUE RECONSTRUCTION. THE SECOND STAGE CONSISTED OF LOCKED PLATES FOR DEFINITIVE INTERNAL FIXATION, USING MINIMALLY INVASIVE PERCUTANEOUS OSTEOSYNTHESIS. WE TREATED 16 CONSECUTIVE PATIENTS (9 WOMEN) WITH OPEN DISTAL TIBIAL FRACTURES USING OUR STAGED PROTOCOL. THE MEDIAN AGE AT TIME OF SURGERY WAS 56 (26¿77) YEARS. THEN A NON-SPANNING EXTERNAL FIXATOR WAS APPLIED, EITHER A LISS-DISTAL FEMUR PLATE (SYNTHES, (B)(4)) OR AN EXTERNAL LOCKED PLATE (ANOTHER MANUFACTURER). ALL PATIENTS WERE ADMITTED FOR DEFINITIVE FIXATION USING MINIMALLY INVASIVE PERCUTANEOUS OSTEOSYNTHESIS WITH DISTAL TIBIAL/METAPHYSEAL PLATES (SYNTHES, (B)(4)) WHEN THE SOFT TISSUE HAD HEALED AFTER MEDIAN 7 (4¿14) WEEKS. 11 PATIENTS HAD GRADE 1 ANKLE ARTHROSIS AND 2 PATIENTS HAD GRADE 2 ANKLE ARTHROSIS. TWO (2) PATIENTS HAD SUPERFICIAL INFECTIONS THAT RESOLVED WITH PARENTERAL ANTIBIOTIC TREATMENT. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159515 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1