BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLY-TAPE OR LEEDS-KEIO CTP

    MDR report key: 680049 · Received February 24, 2006

    Report

    Report Number
    8044102-2006-00001
    Event Type
    Injury
    Date Received
    February 24, 2006
    Report Date
    February 20, 2006
    Manufacturer
    XIROS PLC
    Product Code
    HXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN ORTHOPAEDIC SURGEON HAS TOLD CO ABOUT A SERIES OF INNOVATIVE PROCEDURES HE CONDUCTED STARTING SOME YEARS AGO ON POLIO PATIENTS FOR THE FLAIL FOOT CONDITION. HE USED 50MM WIDE IMPLANTABLE POLYESTER TAPES PROVIDED BY XIROS PLC. THE PROCEDURE IS NOT ONE THAT CO INCLUDES IN CO'S INDICATIONS FOR USE. FIVE PATIENTS IN THE SERIES DEVELOPED NON-HEALING TAPE. THE REPORTED PROBLEMS DO NOT RELATE TO A DEVICE COVERED BY EITHER 510(K) BECAUSE IT IS OUTSIDE THE PERMITTED SIZE RANGE, NOR TO EITHER SET OF INDICATIONS FOR USE. IN THE REPORTED PROCEDURE, THE TAPE IS USED MORE AS A SUPPLEMENTARY ARTIFICIAL LIGAMENT (BONE TO BONE) THAN SOFT TISSUE TO BONE ATTACHMENT. HOWEVER CO BELIEVES THAT THE PRODUCT IS SO SIMILAR TO POLY-TAPES COVERED BY THE 51(K)S THAT THE REPORT MAY BE RELEVANT TO THESE POLY-TAPES. CO BELIEVES THAT THE PRE-EXISTING PATIENT CONDITION MAY HAVE CONTRIBUTED TO THE PROBLEM. OWING TO THE CIRCUMSTANCES OF THE OPERATIONS (FOREIGN COUNTRY, TIME SINCE OPERATIONS) IT HAS NOT BEEN POSSIBLE TO OBTAIN ALL THE INFORMATION REQUIRED CONCERNING THE OPERATIONS PERFORMED AND THE PATIENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLY-TAPE OR LEEDS-KEIO CTP IMPLANTABLE ORTHOPAEDIC TAPE HXT XIROS PLC 50X500MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Disability