BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4 HOLE DOUBLE COMPRESSION PLATE

    MDR report key: 5568147 · Received April 11, 2016

    Report

    Report Number
    1220246-2016-00163
    Event Type
    Injury
    Date Received
    April 11, 2016
    Date of Event
    January 8, 2016
    Report Date
    March 22, 2016
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    PMA / PMN Number
    K130510
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 REQUESTED FOR EVALUATION BUT WAS NOT RETURNED, THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. BASED ON THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE(S) OF THIS EVENT INCLUDES NON-COMPLIANCE TO THE POST-OP PROTOCOL OR POST-OP TRAUMA TO THE SURGICAL SITE. PER DEVICE DIRECTIONS FOR USE (DFU-0192), 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. 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. DEVICE DISCARDED, NOT RETURNING.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT PATIENT UNDERWENT A TALONAVICULAR JOINT PROCEDURE ON (B)(6) 2015. THE AR-8009-20 PLATE WAS IMPLANTED SUCCESSFULLY DURING THE CASE. A FEW WEEKS POST-OP, THE PATIENT CAME BACK TO SURGEON COMPLAINING OF HARDWARE ISSUES. IT WAS DETERMINED THAT THE INNER ARMS ON THE IMPLANT HAD FATIGUED AND BROKE. THIS WAS CONFIRMED WITH AN X-RAY. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2016. DURING THE REVISION PROCEDURE THE AR-8009-20 COMPRESSION PLATE WAS EXPLANTED. TO COMPLETE THE REVISION THE SURGEON IMPLANTED A 4.0 STANDARD COMPRESSION SCREW ACROSS THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223416 4 HOLE DOUBLE COMPRESSION PLATE PLATE, FIXATION, BONE HRS ARTHREX, INC. 163453

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other