BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUSHAPE

    MDR report key: 8807651 · Received July 19, 2019

    Report

    Report Number
    3009196021-2019-00007
    Event Type
    Injury
    Date Received
    July 19, 2019
    Date of Event
    August 2, 2018
    Report Date
    July 18, 2019
    Manufacturer
    MEDCAD
    Product Code
    GXN
    PMA / PMN Number
    K110684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT AND NOT FOR DIAGNOSIS. ON JUNE 19, 2019, MEDCAD RECEIVED A PHONE CALL FROM A DISTRIBUTOR SALES REPRESENTATIVE REQUESTING AN ACCUSHAPE PEEK PATIENT-SPECIFIC IMPLANT FOR A PATIENT FOR WHOM MEDCAD HAD PREVIOUSLY SUPPLIED A PEEK PATIENT-SPECIFIC IMPLANT. ON JUNE 25, 2019, MEDCAD REQUESTED ADDITIONAL INFORMATION REGARDING THE EVENT, VIA EMAIL, INCLUDING THE PATIENT'S WEIGHT. COMMUNICATION WITH THE INITIAL REPORTER VIA TELEPHONE ON JUNE 28, 2019, DETERMINED THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2018. ACCORDING TO COMMUNICATION WITH THE INITIAL REPORTER, THE DEVICE WAS EXPLANTED AFTER THE PATIENT EXPERIENCED DEHISCENCE AT THE INCISION SITE. THE COMPLAINANT ALSO STATED THAT THERE WAS "EVIDENCE OF PNEUMOCEPHALUS UNDERNEATH THE BONE FLAP." THE COMPLAINANT WAS UNABLE TO OBTAIN THE PATIENT'S WEIGHT. REVIEW OF PRODUCTION RECORDS DETERMINED THAT NO NONCONFORMITIES WERE GENERATED DURING THE PRODUCTION OF THE IMPLANT. INVESTIGATION WAS UNABLE TO DETERMINE A CLEAR CAUSE FOR THE REPORTED EVENT. ON (B)(6) 2019, MEDCAD PROVIDED A NEW ACCUSHAPE PEEK PATIENT-SPECIFIC IMPLANT FOR THE PATIENT.

    Description of Event or Problem · 1

    ON JUNE 19, 2019, MEDCAD RECEIVED A PHONE CALL FROM A DISTRIBUTOR SALES REPRESENTATIVE REQUESTING AN ACCUSHAPE PEEK PATIENT-SPECIFIC IMPLANT FOR A PATIENT FOR WHOM MEDCAD HAD PREVIOUSLY PROVIDED A PEEK PATIENT-SPECIFIC IMPLANT. UPON FOLLOW-UP, IT WAS REPORTED BY THE DISTRIBUTOR SALES REPRESENTATIVE THAT THE DEVICE HAD BEEN EXPLANTED, AFTER THE PATIENT EXPERIENCED DEHISCENCE AT THE INCISION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600895 ACCUSHAPE PEEK PATIENT-SPECIFIC IMPLANT GXN MEDCAD 171999 YOU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention