BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDPOR IMPLANT

    MDR report key: 1880543 · Received October 15, 2010

    Report

    Report Number
    1057129-2010-00025
    Event Type
    Other
    Date Received
    October 15, 2010
    Date of Event
    August 6, 2008
    Report Date
    August 10, 2010
    Manufacturer
    POREX SURGICAL
    Product Code
    GWO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT NUMBER 89020-MCI-224-08A-D001G88H, IT WAS DETERMINED THAT ALL PROCESSES AND TEST CRITERIA ARE WITHIN THE MEDPOR CUSTOMIZED IMPLANT FINISHED PRODUCT SPECIFICATION. THE RETAIN SAMPLE OF THE CUSTOMIZED IMPLANT IS A DUPLICATE OF THE IMPLANT SENT TO THE DOCTOR. THE RETAIN WAS COMPARED TO THE IMAGE OF THE DEVICE SENT TO THE DOCTOR FOR HIS APPROVAL. THE RETAIN MATCHED THE IMAGE APPROVED BY THE DOCTOR.

    Description of Event or Problem · 1

    THE POREX SURGICAL SALES REP STATED THAT HE RECEIVED A CALL FROM A DOCTOR DURING THE SURGERY FOR A PT WHO WAS TO RECEIVE A MEDPOR CUSTOMIZED IMPLANT. THE DOCTOR STATED THAT HE WAS UNABLE TO FIXATE THE IMPLANT TO THE PT. THE SALES REP STATED THAT HE RECOMMENDED TO THE DOCTOR TO ROTATE THE IMPLANT IN A CLOCKWISE FASHION TO FIND A CORRECT PLACEMENT POSITION. THE DOCTOR STATED THAT THE IMPLANT DID NOT FIT AND HE DECIDED TO ABANDON THE PLACEMENT OF THE MEDPOR CUSTOMIZED IMPLANT. THE DOCTOR REPORTED THAT HE PROCEEDED WITH THE SURGERY BY USING TITANIUM MESH AND BONE CEMENT TO REPAIR THE DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR IMPLANT MEDPOR CUSTOMIZED SURGICAL IMPLANTS GWO POREX SURGICAL NA MCI-22408AD001G88H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other