BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SU=POR PATIENT-SPECIFIC SURGICAL IMPLANT

    MDR report key: 9530095 · Received December 30, 2019

    Report

    Report Number
    3010781616-2019-00033
    Event Type
    Injury
    Date Received
    December 30, 2019
    Date of Event
    July 15, 2019
    Report Date
    December 5, 2019
    Manufacturer
    PORIFEROUS, LLC
    Product Code
    FWP
    UDI-DI
    00081538502189
    PMA / PMN Number
    K152463
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A BI-LATERAL MANDIBLE + CHIN PSI WAS PRODUCED AND IMPLANTED INTO THE PATIENT (B)(6) 2019 WITH NO COMPLICATIONS OR EXPRESSIONS OF DISSATISFACTION. ON (B)(6) 2019 WE RECEIVED A LETTER STATING THE PATIENT WAS DISSATISFIED AND CITED ASYMMETRY (RIGHT SIDE IS BIGGER AND LOOKS MORE ESTHETIC THAN THE LEFT SIDE), AND AN INDICATION OF AN UNKNOWN INFECTION OF THE SOFT TISSUE ON THE LEFT SIDE. OUR INVESTIGATION INDICATES THAT THE ESTHETICS OF THE LEFT SIDE WERE NOT COMPROMISED DUE TO INFECTION BUT RATHER MISALIGNMENT OF THE RIGHT MANDIBLE. REVIEW OF DESIGN SHOWS THE IMPLANTS WERE SYMMETRICAL. AFTER THE DATA WAS RECEIVED AND REVIEWED ON (B)(6) 2019 IT WAS NOTED THAT THE RIGHT MANDIBULAR IMPLANT WAS NOT POSITIONED FLUSH AGAINST THE RAMUS AS INTENDED RESULTING IN A SYMMETRICAL COSMESIS. DURING THIS TIME THERE WERE NO INDICATIONS MADE STATING THE UNKNOWN INFECTION WAS RELATED TO THE MANUFACTURED DEVICE. THE MAIN FOCUS FOR THE REVISION SURGERY (19-0871)WAS TO MANUFACTURE A NEW/REVISED IMPLANT FREE OF CHARGE TO THE PATIENT TO MIMIC THE RIGHT-SIDE MANDIBLE. REVISION SURGERY PLAN DATE (B)(6) 2019. ROUTINE BACTERIAL ENDOTOXIN TESTING IS PERFORMED BY NELSON LABORATORIES ON ALL BATCHES BEFORE BEING RELEASED FOR DISTRIBUTION. ALL TESTING ASSOCIATED WITH THIS DEVICE IS WITHIN THE ACCEPTANCE CRITERIA. RECORDS ARE AVAILABLE UPON REQUEST. ALL VALIDATIONS AND PROCESS CONTROLS FOR THE DEVICE WERE FOUND TO BE CONSISTENT AND IN THE VALIDATED RANGE.

    Description of Event or Problem · 1

    PATIENT RECEIVED BILATERAL PATIENT SPECIFIC MANDIBULAR IMPLANTS. LEFT SIDE SOFT TISSUE BECAME INFECTED AND EXPOSED. THE PATIENT WAS ADVISED BY THE SURGEON OF POST-OPERATIVE CARE,INCLUDING AVOIDING TOUCHING THE IMPLANTATION SITE AS WELL AS AVOIDANCE OF PROLONGED, SIGNIFICANT,COMPRESSIVE STRESSES. THE SURGEON INDICATED THAT THE PATIENT WAS NOT COMPLIANT WITH POST-OPERATIVE INSTRUCTIONS. CONSERVATIVE TREATMENT OF THE INFECTION WITH ANTIBIOTIC WAS ATTEMPTED BUT WAS UNSUCCESSFUL. PATIENT REQUESTED A NEW IMPLANT BE MANUFACTURED TO REPLACE THE LEFT MANDIBULAR IMPLANT. SURGICAL INTERVENTION WAS REQUIRED ON (B)(6) 2019 TO REMOVE AND REPLACE THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1324431 SU=POR PATIENT-SPECIFIC SURGICAL IMPLANT SU-POR SURGICAL IMPLANTS FWP PORIFEROUS, LLC 18-0703 435319029011 00081538502189

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention