BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4 HOLE DBL COMP PLATE, SQUARE, 20MM

    MDR report key: 4722350 · Received April 23, 2015

    Report

    Report Number
    1220246-2015-00097
    Event Type
    Injury
    Date Received
    April 23, 2015
    Date of Event
    April 1, 2015
    Report Date
    April 1, 2015
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    PMA / PMN Number
    K130510
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (DATE OF BIRTH, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS RECEIVED AND AN EVALUATION WAS CONDUCTED. THE COMPLAINT WAS CONFIRMED. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE DEVICE MET ALL MATERIAL SPECIFICATIONS AS RECEIVED. THE EVALUATION REVEALED THAT THE RETURNED DOUBLE COMPRESSION PLATE IS BROKEN IN HALF. BASED ON THE EVENT DESCRIPTION, WHERE IT WAS NOTED THAT THE DEVICE FAILED ABOUT 10 WEEKS POST-OPERATIVELY AND THAT THE PATIENT WAS IN FULL COMPLIANCE AT THE TIME OF REMOVAL, THE MOST LIKELY CAUSE(S) FOR THE COMPLAINANT'S EVENT INCLUDE IN-VIVO LOADING OF THE DEVICE POSSIBLY CAUSING A FATIGUE FRACTURE AND POSSIBLY IN CONJUNCTION WITH BENDING/STRESSING THE PLATE PRIOR TO IMPLANTATION AS WELL AS PATIENT NON-COMPLIANCE WITH THE POST-OP PROTOCOL. PER PRODUCT DIRECTIONS FOR USE (DFU-0192), POST-OPERATIVELY, UNTIL BONE HEALING IS COMPLETE, FIXATION GIVEN WITH THIS DEVICE SHOULD BE CONSIDERED AS TEMPORARY AND MAY NOT WITHSTAND WEIGHT BEARING OR OTHER UNSUPPORTED STRESS AND UNTIL HEALING IS COMPLETE THE FIXATION PROVIDED BY THIS DEVICE SHOULD BE PROTECTED. THE POST-OPERATIVE REGIMEN PRESCRIBED BY THE PHYSICIAN SHOULD BE STRICTLY FOLLOWED TO AVOID ADVERSE STRESSES APPLIED TO THE DEVICE. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PAIN IN THE JOINT POST-OP. AN X-RAY WAS TAKEN. PLATE WAS BROKEN AND JOINT DID NOT FUSE. PLATE WAS REMOVED, SURGEON PUT BONE GRAFT AND ANOTHER ARTHREX PLATE. CALLER STATES PATIENT WAS POST-OP COMPLIANT. REVISION DATE (B)(6) 2015, ORIGINAL DOS APPROX 10 WEEKS PRIOR. CASE, TALAR NAVICULAR ARTHRODESIS. FOLLOW-UP INVESTIGATION: THE ORIGINAL SURGERY DATE WAS (B)(6) 2014. THE REVISION SURGERY WAS DUE TO A NON-UNION OF THE REPAIR. THE PLATE WAS REMOVED AND THE BONE WAS CLEANED USING A ROGUE AND RE-PREPPED WITH BONE GRAFT. ANOTHER AR-8009-20 PLATE WAS INSERTED TO COMPLETE THE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268892 4 HOLE DBL COMP PLATE, SQUARE, 20MM PLATE, FIXATION, BONE HRS ARTHREX, INC. 140248

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other