BEUDAMED
    FDA Adverse Event Other Summary report: N

    VIPER DISTAL VOLAR RADIUS PLATE IMPLANT

    MDR report key: 817766 · Received June 8, 2006

    Report

    Report Number
    2028840-2006-00009
    Event Type
    Other
    Date Received
    June 8, 2006
    Date of Event
    June 2, 2006
    Report Date
    June 6, 2006
    Manufacturer
    KINETIKOS MEDICAL, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    KMI FIELD REP ATTENDED THE EXPLANT SURGERY, PERFORMED BY DR INDICATED THAT ONE OF THE SIX SINGLE LOCKING SCREWS USED [LOCATED IN THE PLATES DISTAL ROW] APPEARED SIGNIFICANTLY MORE PROMINENT THEN THE OTHER FIVE. IT WAS NOTED THAT THE PATIENT'S PREVIOUS DISTAL RADIAL FRACTURE HAD HEALED CORRECTLY, CONFIRMING THAT THE DEVICE HAD PERFORMED AS DESIGNED (REDUCTION OF DISTAL RADIUS FRACTURES), WHICH FACILITATED THE REMOVAL OF THE DISTAL VOLAR PLATE, LOCKING SCREWS AND CANCELLOUS SCREWS THAT CONSTITUTE THE COMPLETE IMPLANT SYSTEM. HOWEVER, THE ONE PROTRUDING SCREW OBSERVED APPARENTLY RESULTED IN OR EXACERBATED A RUPTURED TENDON. A TENDON TRANSFER WAS PERFORMED TO COMPENSATE FOR THE TENDON DAMAGE. AS THERE WERE NO BROKEN, BENT OR DAMAGED COMPONENTS OBSERVED UPON THEIR REMOVAL, THE CONSENSUS WAS THAT THE ONE PROMINENT LOCKING SCREW HAD NOT BEEN PROPERLY OR COMPLETELY LOCKED IN TO POSITION AS REQUIRED DURING THE ORIGINAL SURGERY. A REVIEW OF THE SURGICAL TECHNIQUE REVEALED THAT THE METHOD FOR SECURING THE LOCKING SCREWS IS AND HAS ALWAYS BEEN ARTICULATED IN SUFFICIENT DETAIL, WHICH HAS BEEN BORNE OUT BY THE PRODUCT LINES SUCCESS RATE. THE ORIGINAL IMPLANTING PHYSICIAN'S IDENTITY HAS NOT BEEN DETERMINED. IT WAS DETERMINED THAT FOLLOWING THE STANDARD-PRACTICE POST-EXPLANT STERILIZATION OF THE REMOVED COMPONENTS, ALL WERE DISCARDED BY HOSPITAL PERSONNEL AND WERE THEREFORE NOT MADE AVAILABLE TO KMI CORPORATE HEADQUARTERS FOR EVALUATION. GIVEN THE ABSENCE OF PRODUCT INPUT OR ANY OTHER INFORMATION THAT WOULD SUGGEST A DEFICIENCY IN THIS DEVICE SYSTEMS DESIGN, NO CORRECTIVE ACTION OR PREVENTIVE ACTIONS ARE BEING PRESCRIBED AT THIS TIME. PER KMI PROCEDURE, POST-MARKET SURVEILLANCE WILL CONTINUE TO DETERMINE IF ADDITIONAL COMPONENT SIZES, MINOR CONFIGURATION MODIFICATIONS OR OTHER CHANGES MAY BE DESIRED TO MEET SURGEON/PATIENT NEEDS TO ENSURE THE EFFECTIVE REDUCTION OF DISTAL RADIAL FRACTURES. [ SEE SCANNED PAGES].

    Description of Event or Problem · 1

    IN 2006, KINETIKOS MEDICAL, INC., WAS INFORMED OF THE EXPLANT OF A VIPER DISTAL VOLAR RADIUS PLATE IMPLANT SYSTEM FROM A MALE PATIENT TO PAIN APPROXIMATELY 6 MONTHS FOLLOWING THE ORIGINAL IMPLANTATION. SURGERY HAD BEEN PERFORMED AT 8:00 OF THAT MORNING. THE EXPLANTED COMPONENTS WERE NOT RETURNED TO KMI FOR EVALUATION. NO PRODUCT DEFECTS OR NON-CONFORMITIES WERE OBSERVED DURING THE EXPLANT SURGERY. THE DISTAL RADIAL FRACTURE HAD HEALED AS DESIRED. THE PATIENT'S RECOVERY PROGNOSIS WAS GOOD. THE SAME DAY, KMI RECEIVED NOTIFICATION OF AN EXPLANT OF A VIPER DISTAL VOLAR RADIUS PLATE & SCREWS FROM A PATIENT BY DR. THE EXPLANT WAS PERFORMED TO ADDRESS PAIN REPORTED BY THE PATIENT. THE ORIGINAL IMPLANT DATE WAS REPORTED AS APPROXIMATELY SIX (6) MONTHS PREVIOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIPER DISTAL VOLAR RADIUS PLATE IMPLANT ORTHOPEDIC WRIST/FOREARM IMPLANT HRS KINETIKOS MEDICAL, INC. 28-0XXX NOT INDICATED

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other