BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEOMATCH

    MDR report key: 7077306 · Received December 1, 2017

    Report

    Report Number
    3009196021-2017-00001
    Event Type
    Injury
    Date Received
    December 1, 2017
    Date of Event
    February 1, 2017
    Report Date
    December 1, 2017
    Manufacturer
    MEDCAD
    Product Code
    GXN
    PMA / PMN Number
    K110684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT AND NOT FOR DIAGNOSIS. EVALUATION OF THE DEVICE COULD NOT BE COMPLETED AS NO DEVICE WAS RETURNED TO MEDCAD. THE DEVICE IS NOT EXPECTED TO BE RETURNED AS IT WAS DISCARDED AFTER EXPLANT. IT WAS REPORTED BY THE DISTRIBUTOR THAT PRIOR TO THE IMPLANTATION OF THE PEEK PSI, THE PATIENT HAD UNDERGONE THREE DIFFERENT SURGERIES AT THE SAME SITE; AND THAT THE PATIENT HAD PREVIOUSLY EXPERIENCED INFECTION. INFORMATION OBTAINED FROM THE DISTRIBUTOR REVEALED THAT THE PATIENT HAS A CONDITION CALLED MYOEPITHELIOMA, WHICH IS A BENIGN SPREADING TUMOR THAT, IF NOT PROPERLY REMOVED, WILL CONTINUE TO RESURFACE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) AND A REVIEW OF THE LABELING FOR THIS SPECIFIC LOT NUMBER WERE PERFORMED. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE CONDITION DESCRIBED BY THE REPORTER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, IT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DISTRIBUTOR THAT AN OSTEOMATCH PEEK PATIENT-SPECIFIC IMPLANT (PSI), AS WELL AS SUPPORTING OSTEOMED FIXATION PLATES (P/N 218-0095) AND SCREWS (P/N 211-1604), WERE REMOVED FROM A PATIENT. EXACT DATE OF IMPLANT AND EXACT DATE OF EXPLANT ARE UNKNOWN. PER THE INFORMATION RECEIVED FROM THE DISTRIBUTOR, THE SURGEON REPORTED THAT PRIOR TO THE IMPLANTATION OF THE PEEK (POLY-ETHER-ETHER-KETONE) PSI, THE PATIENT HAD UNDERGONE THREE 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 RECIEVED 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 IF NOT PROPERLY REMOVED WILL CONTINUE TO RESURFACE. THE PATIENT'S STATUS AS OF MARCH 2017 WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853306 OSTEOMATCH PEEK IMPLANT 100-150 SQ CM GXN MEDCAD 161446 SHA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention