BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFIT CB PLUG KITS

    MDR report key: 2032230 · Received March 29, 2011

    Report

    Report Number
    1219602-2011-00050
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    September 1, 2010
    Report Date
    December 13, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY
    Product Code
    MQV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(6) 2009: ARTHROSCOPY WITH IMPLANTATION OF 1 TRUFIT PLUG: 11 MM DIAMETER, 12MM LONG MRI'S TAKEN; SURGEON EVALUATED THE MRI'S AND CONCLUDED THAT THERE MIGHT BE GRAFT INCORPORATION AS THERE WAS: A LIGHT GREY APPEARANCE AT THE REPAIR SITE AND ROUNDED EDGES AT THE DISTAL PART OF THE REPAIR TISSUE. HE CONCLUDED THAT THERE MIGHT BE DELAYED INCORPORATION OF THE PLUG AND SUGGESTED NOT TO DO ANY SURGERY AND WAIT FOR ANOTHER 6 MONTHS. THEN, ACCORDING TO MRI AND SYMPTOMS, RE-EVALUATION SHOULD HAPPEN. PATIENT IS HAVING PAIN 18 MONTHS AFTER TRUFIT IMPLANTATION. THE PAIN OCCURS AFTER SPORTS ACTIVITIES AND AT LONG TERM WEIGHT BEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFIT CB PLUG KITS TRUFIT CB PLUG, PURPLE, 11MM MQV SMITH & NEPHEW ENDOSCOPY 72200936 50258037

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR