BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIO-CORKSCREW SUTURE ANCHOR W/FIBERWIRE

    MDR report key: 1371602 · Received February 10, 2009

    Report

    Report Number
    1220246-2009-00007
    Event Type
    Other
    Date Received
    February 10, 2009
    Date of Event
    January 1, 2009
    Report Date
    January 15, 2009
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K061863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED FOR EVALUATION BUT WAS NOT RETURNED, THEREFORE, THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AND THE MANUFACTURING DATE COULD NOT BE DETERMINED. THE ISSUE IS MOST LIKELY RELATED TO AN ADVERSE REACTION OF THE PATIENT TO THE MATERIAL(S) IMPLANTED. PRODUCT DFU WARNS OF A POSSIBLE ALLERGIC REACTION TO THE IMPLANT MATERIALS. PATIENT SENSITIVITY SHOULD ALWAYS BE CONSIDERED/RULE OUT PRIOR TO THE PROCEDURE. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF THE DEVICE IS RETURNED AND ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS HAD AN ALLERGIC REACTION THE FIBER WIRE SUTURE USED TO REPAIR A DELTOID OPENING FOR A MINI-OPEN ROTATOR CUFF REPAIR. THE DATE OF THE ORIGINAL SURGERY/IMPLANTATION OF THE DEVICE WAS (B)(6) 2008. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO MULTIPLE FOLLOW-UP COMMUNICATION REQUESTS. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-CORKSCREW SUTURE ANCHOR W/FIBERWIRE HWC ARTHREX, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other INFORMATION REQUESTED BUT NOT PROVIDED