BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE ANCH BIOCOMP SWI- VELOCK C CLD 4.75X19.1MM

    MDR report key: 2923717 · Received January 22, 2013

    Report

    Report Number
    1220246-2012-00273
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    April 6, 2012
    Report Date
    December 27, 2012
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K101823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 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 POSSIBLE FOREIGN BODY AND ALLERGIC-LIKE REACTIONS 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 FOLLOWING A ROTATOR CUFF REPAIR, THE PATIENT DEVELOPED PAIN. AN MRI REVEALED A CYST FORMING AROUND THE AREA OF THE ANCHORS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29071 SUTURE ANCH BIOCOMP SWI- VELOCK C CLD 4.75X19.1MM FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 476735

    Patients

    Seq Age Sex Outcome Treatment
    1 Other