BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3813770 · Received May 15, 2014

    Report

    Report Number
    2520274-2014-11344
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 24, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FOR TREATMENT, NOT DIAGNOSIS. ¿PRIMARY BLADE PLATE ARTHRODESIS FOR UNRECONSTRUCTABLE DISTAL TIBIA FRACTURES.¿ THIS REPORT IS FOR UNKNOWN BLADE PLATES/UNKNOWN LOTS. 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 ARTICLE, ¿PRIMARY BLADE PLATE ARTHRODESIS FOR UNRECONSTRUCTABLE DISTAL TIBIA FRACTURES.¿ JOHNSON, M.D., KINER, D.W., AND NOWOTARSKI, P.J. (DECEMBER 2013). TECHNIQUES IN FOOT AND ANKLE SURGERY, VOLUME 12, NUMBER 4, 220-227. IT WAS REPORTED, THAT IN THEIR INSTITUTION, THE DOCTORS HAD BEEN PERFORMING A POSTEROLATERAL APPROACH TO THE TIBIOTALAR JOINT AND SHAFT TO PERFORM SUBACUTE ARTHRODESES UTILIZING A 90-DEGREE CANNULATED BLADE PLATE (SYNTHES, (B)(4)) FOR THE PAST 15 YEARS. A RETROSPECTIVE CASE SERIES REPORTS THE OUTCOMES OF ADULTS UNDERGOING PRIMARY BLADE PLATE FUSION FOR UNRECONSTRUCTABLE PILON FRACTURES. PATIENTS WHO WERE SKELETALLY MATURE AT THE TIME OF INJURY, ADMITTED TO THE HOSPITAL BETWEEN JANUARY 2002 AND JUNE 2011 AND UNDERWENT PRIMARY BLADE PLATE FUSION WERE IDENTIFIED AND INCLUDED IN THE STUDY POPULATION. TWELVE PATIENTS FIT THE INCLUSION CRITERIA. THESE TWELVE PATIENTS RECEIVED PRIMARY BLADE PLATE FUSION FOR UNRECONSTRUCTABLE DISTAL TIBIA FRACTURES OVER A 10-YEAR PERIOD (2002 TO 2011). THERE WERE 9 MALES AND 3 FEMALES WITH AVERAGE AGE 37.8 YEARS (RANGE, 28 TO 47). ONE PATIENT, A SMOKER, WITH A III-B OPEN FRACTURE DEVELOPED A DEEP INFECTION AND ELECTED TO UNDERGO A BELOW THE KNEE AMPUTATION. TWO PATIENTS DEVELOPED METAPHYSEAL NONUNIONS REQUIRING REVISION BLADE PLATE FUSION WITH BONE GRAFTING OF THE NONUNION. BOTH PATIENTS SUCCESSFULLY HEALED THEIR ARTHRODESIS BUT HAD A PERSISTENT NONUNION OF THEIR METAPHYSEAL COMMINUTION. BOTH PATIENTS HEALED THEIR NONUNIONS AFTER REPEAT PLATING AND BONE GRAFTING. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR UNKNOWN BLADE PLATES. NO REPORTED PRODUCT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291077 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention