BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEEK

    MDR report key: 6515400 · Received April 24, 2017

    Report

    Report Number
    2027754-2017-00005
    Event Type
    Injury
    Date Received
    April 24, 2017
    Date of Event
    February 28, 2017
    Report Date
    June 2, 2017
    Manufacturer
    OSTEOMED
    Product Code
    GXN
    PMA / PMN Number
    K110684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXACT ROOT CAUSE IS UNKNOWN. THE IMPLANT WAS NOT RETURNED FOR EVALUATION. PER THE INVESTIGATION COMPLETED BY THE MANUFACTURER, MEDCAD, THERE WERE NO ISSUES FOUND WITHIN THE DHR, MANUFACTURING, OR LABELING THAT WOULD CONTRIBUTE TO THIS INCIDENT. INFORMATION OBTAINED BY MEDCAD REVEALED THAT THE PATIENT HAS A CONDITION CALLED MYOEPITHELIOMA. THIS IS A BENIGN SPREADING TUMOR THAT, IF NOT PROPERLY REMOVED, WILL CONTINUE TO RESURFACE. THIS PRODUCT WAS MANUFACTURED AND SHIPPED DIRECTLY TO THE CUSTOMER. THEREFORE, AN INTERNAL DHR WAS NOT CREATED. THE REVIEW OF OSTEOMED CAPA AND NCRS DID NOT IDENTIFY ANY INTERNAL INVESTIGATIONS FOR THIS DEVICE. THE REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ONE (1) SIMILAR COMPLAINT. A REVIEW OF THE OSTEOMATCH PEEK PATIENT SPECIFIC CRANIAL IMPLANT INSTRUCTIONS FOR USE (P/N 030-1706), REV. A, PROVIDES WARNINGS AND PRECAUTIONS RELATED TO USE, AND PROVIDES VALIDATED STERILIZATION PARAMETERS TO ENSURE THE IMPLANT IS STERILE. THIS ISSUE WILL BE MONITORED THROUGH ROUTINE TRENDING.

    Description of Event or Problem · 1

    ON APRIL 11, OSTEOMED QA WAS NOTIFIED OF AN INCIDENT WITH THE OSTEOMATCH PEEK IMPLANT 100 - 150 SQ CM (P/N ACSM-002). THIS INCIDENT WAS INITIALLY REPORTED TO MEDCAD, THE MANUFACTURER OF THIS PRODUCT DISTRIBUTED BY OSTEOMED (MDR 3009196021-2017-00001). PER THE INFORMATION RECEIVED FROM MEDCAD, A PATIENT-SPECIFIC IMPLANT (PSI) WAS REMOVED FROM A FEMALE PATIENT DUE TO AN INFECTION. THE PSI WAS ORIGINALLY IMPLANTED IN (B)(6) 2016. PRIOR TO THE IMPLANTATION OF THE PEEK (POLY-ETHER-ETHER-KETONE) PSI, THE PATIENT HAD UNDERGONE THREE (3) DIFFERENT SURGERIES AT THE SAME SITE. IN THE FIRST SURGERY, THE ORIGINAL (AUTOLOGOUS) BONE FLAP WAS REMOVED. IN THE SECOND SURGERY, THE ORIGINAL BONE FLAP WAS RE-IMPLANTED AND THE SITE BECAME INFECTED. IN THE THIRD SURGERY, THE PATIENT RECEIVED A POLYMETHYL METHACRYLATE IMPLANT AND THE SITE BECAME INFECTED AGAIN. IT WAS REPORTED THAT THE PATIENT HAS A CONDITION CALLED MYOEPITHELIOMA, WHICH IS A BENIGN SPREADING TUMOR THAT WILL CONTINUE TO RESURFACE IF NOT PROPERLY REMOVED. A SURGERY WAS PERFORMED WHICH REMOVED ONE SIDE OF THE TRANSVERSE SINUS, REMOVED PATIENT'S SKULL FROM THE PARIETAL AND OCCIPITAL REGION, AND REMOVED A GRAFT FROM PATIENT'S SHOULDER TO REPLACE IN THE CERVICAL REGION OF THE NECK. THE PATIENT STATUS AS OF (B)(6) 2017 WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298402 PEEK OSTEOMATCH PEEK IMPLANT 100-150 SQ CM GXN OSTEOMED 161446 SHA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention