BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM DESIGNS MEDICAL CUSTOM IMPLANT

    MDR report key: 3231969 · Received July 8, 2013

    Report

    Report Number
    2028306-2013-00001
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 8, 2013
    Manufacturer
    SPECTRUM DESIGNS, INC., DBA SPECTRUM DESIGNS MEDICAL
    Product Code
    FWM
    PMA / PMN Number
    NONE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN ASKED IF HE COULD RETURN THE IMPLANT TO HAVE IT RE STERILIZED, AND SPECTRUM DESIGNS DECLINED THIS REQUEST. SPECTRUM DESIGNS MEDICAL ALSO DECLINED TO HAVE THE IMPLANT RETURNED FOR EVAL BECAUSE WITH THE IMPLANT IN ITS CONTAMINATED STATE, THERE WOULD BE NO WAY FOR US TO INVESTIGATE THE SOURCE OF THE INFECTION WHETHER IT WAS FROM BACTERIA ON THE IMPLANT AFTER STERILIZATION, OR FROM BACTERIA PRESENT SOMEWHERE ELSE DURING THE SURGERY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PHYSICIAN CALLED TO REPORT THAT HIS PT, WHOM HE IMPLANTED A SPECTRUM DESIGNS MEDICAL CUSTOM IMPLANT INTO, EARLIER IN THE MONTH HAD TO UNDERGO SURGERY TO REMOVE THE IMPLANT, AND WAS HOSPITALIZED DUE TO INFECTION. THE PHYSICIAN REQUESTED THAT THE STERILIZATION DOCUMENTS FOR THE IMPLANT BE SENT, AND THEY WERE FAXED TO HIM PER HIS REQUEST ON (B)(6) 2013. ACCORDING TO THE PHONE CONVERSATION, THE PHYSICIAN WAS ATTEMPTING TO DETERMINE THE SOURCE OF THE STAPH INFECTION. SPECTRUM DESIGNS DOES NOT HAVE ANY OTHER REPORTED INCIDENTS OF INFECTION FROM ANY OTHER IMPLANTS STERILIZED DURING THIS TIME PERIOD. ALL BATCH AND STERILIZATION RECORDS ARE COMPLETE AND DO NOT INDICATE ANY STERILITY FAILURES. THE PHYSICIAN INQUIRED WHETHER WE COULD RE-STERILIZE THE DEVICE FOR RE-IMPLANTATION IN THE PT, AND SPECTRUM DESIGNS MEDICAL RESPONDED THAT THE IMPLANT IS SINGLE USE, AND SHOULD NOT BE RE-IMPLANTED IN THE PT. SDM HAS OFFERED TO RE-MOLD THE IMPLANT, HOWEVER IT IS UNK WHETHER THE PT WILL UNDERGO ADD'L SURGERY TO RE-CORRECT HIS PECTORAL DEFORMITY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308777 SPECTRUM DESIGNS MEDICAL CUSTOM IMPLANT SOLID SILICONE CUSTOM IMPLANT, STERILE FWM SPECTRUM DESIGNS, INC., DBA SPECTRUM DESIGNS MEDICAL CUSTOM IMPLANT 34851

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization