BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLY-TAPE, 20 X 500MM

    MDR report key: 2366355 · Received December 6, 2011

    Report

    Report Number
    8044102-2011-00001
    Event Type
    Injury
    Date Received
    December 6, 2011
    Date of Event
    July 1, 2011
    Report Date
    December 1, 2011
    Manufacturer
    XIROS
    Product Code
    JDR
    PMA / PMN Number
    K010051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE REPORTING THIS ADVERSE EVENT TO THE FDA AS A PRECAUTIONARY MEASURE SINCE IT OCCURRED AFTER A REPAIR USING A POLY-TAPE (20 X 500MM) (K010051). THE EVENT OCCURRED IN (B)(6). THE POLY-TAPE WAS BEING USED FOR A SPECIFIC PROCEDURE FOR WHICH WE HAVE NOT SUBMITTED A SPECIFIC INDICATION FOR USE IN THE USA. INDEED, THE 510K APPLICABLE TO THIS PRODUCT DESCRIBES THE USE OF THE POLY-TAPE WITH A FASTLOK FIXATION DEVICE; IN THE SURGICAL TECHNIQUE USED IN CONNECTION WITH THIS REPORTABLE EVENT, A FASTLOK FIXATION DEVICE IS NOT USED. FOR THESE REASONS, WE WOULD NOT SUSPECT THAT THE ADVERSE EVENT COULD BE REPLICATED IN THE USA. WE ARE STILL TRYING TO GAIN EVIDENCE FROM OUR DISTRIBUTOR TO HELP US DETERMINE THE ROOT CAUSE OF THE ADVERSE EVENT. AT THIS POINT IN TIME WE HAVE SEVERAL THEORIES AS TO THE POSSIBLE CAUSE. WE ARE WORKING WITH OUR DISTRIBUTOR TO TRY TO GAIN FURTHER INFO TO ALLOW US TO DETERMINE WHICH IF ANY OF THESE POSSIBILITIES WAS THE ROOT CAUSE, AND THEREFORE WHAT IF ANY REMEDIAL ACTION WE NEED TO TAKE.

    Description of Event or Problem · 1

    A 20MM X 500MM POLY-TAPE HAD BEEN USED FOR ACROMIOCLAVICULAR JOINT REPAIR ON (B)(6) 2011 IN (B)(6). IT WAS REPORTED THAT THREE WEEKS AFTER SURGERY, THE PT FELT/HEARD A "GRINDING" IN THE SHOULDER. A USG REVEALED A RUPTURE OF THE POLY-TAPE, WHICH HAD TO BE EXPLANTED AND A REVISION CARRIED OUT. INITIAL REPORTS SUGGEST THAT THE CORACOID PROCESS WAS ALSO DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLY-TAPE, 20 X 500MM SUTURE, NON-ABSORBABLE SYNTHETIC PET JDR XIROS 103-1012 280407

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention