BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUSHAPE

    MDR report key: 7065427 · Received November 28, 2017

    Report

    Report Number
    3009196021-2017-00007
    Event Type
    Injury
    Date Received
    November 28, 2017
    Date of Event
    January 1, 2017
    Report Date
    March 23, 2018
    Manufacturer
    MEDCAD
    Product Code
    GXN
    PMA / PMN Number
    K110684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE'S PRODUCTION RECORDS REVEALED THAT THE DEVICE WAS MANUFACTURED IN COMPLIANCE WITH MEDCAD'S MANUFACTURING PROCEDURES. MEDCAD WAS NOTIFIED ON 03/23/2017 BY THE COMPLAINANT VIA PHONE CALL THAT THE DEVICE HAD BEEN HANDLED IN A WAY THAT WAS NOT IN ACCORDANCE WITH THE SPECIFICATION PROVIDED IN THE INSTRUCTIONS FOR USE. SPECIFICALLY, FIXATION MATERIALS WERE ADDED TO THE IMPLANT PRIOR TO STERILIZATION. REVIEW OF THE DEVICE'S LABELING REVEALED THAT INSTRUCTIONS FOR USE WERE PROVIDED THAT INCLUDED CONTRAINDICATIONS, WARNINGS AND STERILIZATION INSTRUCTIONS TO BE USED TO ENSURE THAT THE IMPLANT IS STERILE. REQUESTS FOR ADDITIONAL INFORMATION, INCLUDING PATIENT'S WEIGHT, WERE ATTEMPTED ON 10/19/2017 VIA EMAIL AND 10/24/2017 VIA PHONE. MEDCAD HAS NOT RECEIVED FURTHER INFORMATION FROM THE COMPLAINANT.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT AND NOT FOR DIAGNOSIS. EVALUATION OF THE DEVICE COULD NOT BE COMPLETED AS THE DEVICE WAS DISCARDED AFTER EXPLANT. THE EXACT DATE OF IMPLANT AND EXACT DATE OF EXPLANT ARE UNKNOWN. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS SPECIFIC LOT NUMBER WAS PERFORMED. A REVIEW OF THE LABELING AND PRODUCTION RECORDS FOR THIS LOT NUMBER WAS ALSO PERFORMED. EVALUATION FOR THIS EVENT IS STILL IN PROGRESS. A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE ONCE EVALUATION IS COMPLETE OR IF ADDITIONAL INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT.

    Description of Event or Problem · 1

    ON MARCH 3, 2017, MEDCAD RECEIVED NOTIFICATION FROM A SALES REPRESENTATIVE THAT AN ACCUSHAPE PEEK PATIENT-SPECIFIC IMPLANT WAS REMOVED FROM A PATIENT. IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE DEVICE WAS IMPLANTED IN (B)(6) 2016, AND THAT THE DEVICE WAS REMOVED IN 2017 AFTER THE PATIENT EXPERIENCED AN INFECTION. EXACT DATE OF IMPLANT AND EXACT DATE OF EXPLANT ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842327 ACCUSHAPE PEEK PATIENT-SPECIFIC IMPLANT GXN MEDCAD 161517 MAX

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention