BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE ANCH BIOCOMP SWI- VELOCK C, CLD 5.5X19.1MM

    MDR report key: 3233755 · Received July 18, 2013

    Report

    Report Number
    1220246-2013-00125
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K101823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, 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 DEVICES WERE REQUESTED FOR EVALUATION BUT REMAIN 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. LOT NUMBER WAS NOT PROVIDED SO DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. 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. 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 THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED 2 MONTHS POST-OP, REACTION ON (B)(6) 2013. PATIENT HAD A ROTATOR CUFF REPAIR. IMPLANTS USED WERE BIO SWIVELOCK 5.5 MM, BIO TENODESIS, FIBERTAPE. THE PATIENT HAS RELOCATED TO ANOTHER STATE AND AS OF (B)(6) 2013 IS NOW UNDER THE CARE OF A DIFFERENT SURGEON FOR A RASH ON HIS SHOULDER AT THE INSERTION SITE. THE RASH IS SPREADING TO DIFFERENT LOCATIONS ON HIS BODY, SHOULDER TO ARM THEN LEG AND KNEE. (B)(6) 2013 FOLLOW UP VISIT. THE PATIENT WOULD LIKE TO HAVE ALL OF THE DEVICES REMOVED AND IS CURRENTLY SEEING AN ALLERGIST TO SEE IF ANYTHING CAN BE DETERMINED. HE IS NOT A DIABETIC. PER SECOND SURGEON, THIS WOULD REQUIRE THE REMOVAL AND INSERTION OF BONE PLUGS AND THE REPOSITIONING OF THE CUFF FOR ADDITIONAL IMPLANTS FOR ANOTHER REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333752 SUTURE ANCH BIOCOMP SWI- VELOCK C, CLD 5.5X19.1MM FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AR-7237-7, FIBERTAPE, LOT # UNKNOWN.| AR-1570B, BIO-TENODESIS SCREW, LOT # UNKNOWN.