BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE ANCHOR, BIO-CORKSCREW FT

    MDR report key: 3043497 · Received April 9, 2013

    Report

    Report Number
    1220246-2013-00050
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 27, 2012
    Report Date
    March 15, 2013
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K082810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS REQUESTED FOR EVALUATION BUT REMAINS IN THE PATIENT AND CANNOT BE 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. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE MOST LIKELY CAUSE OF THIS TYPE OF EVENT IS AN ADVERSE REACTION OF THE PATIENT TO THE MATERIAL(S) IMPLANTED. PRODUCT DIRECTIONS FOR USE WARNS OF ADVERSE EFFECTS LIKE FOREIGN BODY AND ALLERGIC-LIKE REACTIONS AS WELL AS INFECTIONS BOTH DEEP AND SUPERFICIAL TO THE IMPLANT MATERIALS. PATIENT SENSITIVITY TO DEVICE MATERIALS MUST BE CONSIDERED PRIOR TO IMPLANTATION. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. PART REMAINS IN PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PATIENT REACTION TO BIO-COMPOSITE IMPLANTS. PATIENT HAD A GLUTEUS MAXIMUS REPAIR (DETACH AND REPAIR GLUTEAL TENDON TO RIGHT HIP) ON (B)(6) 2012 USING BIO- COMPOSITE SCREWS. ABOUT 6 WEEKS POST-OP SHE BEGAN TO HAVE BURNING AND SWELLING. SHE HAD AN MRI & MRA DONE. BRUISING BEGAN TO SHOW AT THE INSERTION SITES (LOOKS LIKE FINGER PRINTS). FROM (B)(6) 2012, PAINFUL SORES HAD DEVELOPED AT EACH INSERTION SITE. A WHITE "TOOTHPASTE" LIKE SUBSTANCE BEGAN TO LEAK OUT FROM THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146219 SUTURE ANCHOR, BIO-CORKSCREW FT FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 431561

    Patients

    Seq Age Sex Outcome Treatment
    1 Other (B)(4), LOT 479266.