BEUDAMED
    FDA Adverse Event Other Summary report: N

    WRIST FUSION SYSTEM

    MDR report key: 748812 · Received August 11, 2006

    Report

    Report Number
    2028840-2006-00015
    Event Type
    Other
    Date Received
    August 11, 2006
    Date of Event
    July 19, 2006
    Report Date
    August 8, 2006
    Manufacturer
    KINETIKOS MEDICAL, INC.
    Product Code
    KWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    KINETIKOS MEDICAL, INC SUB-REP WAS PRESENT AT THE EXPLANT SURGERY IN 2006. THE PT HAD REGISTERED WRIST PAIN. THE PT'S BONE QUALITY (DENSITY) WAS REPORTED AS 'NORMAL'. THE DESIRED FOUR-CORNER FUSION OF THE CARPAL BONES HAD NOT OCCURRED. ONE BONE SCREW APPEARED TOO LONG FOR THE PARTICULAR LOCATION IT WAS POSITIONED IN (HAVING PROTRUDED THROUGH AND IN TO AN UNSPECIFIED CARPAL BONE JOINT). ANOTHER BONE SCREW HAD BROKEN AT THE HEAD CLOSE TO THE PLATE. THE PT WAS NOT ASKED ABOUT A TRAUMATIC EVENT THAT COULD HAVE PRECIPITATED THE BREAKAGE. NO COMPONENTS WERE RETURNED TO KMI FOR EVAL AS THE PT INSISTED ON KEEPING THEM FOR HIMSELF. THE SUBJECT BONE SCREW LOT FILE COULD THEREFORE NOT BE RESEARCHED. THE EXPLANTING PHYSICIAN DOES NOT USE THE SPIDER WRIST FUSION SYSTEM FOR FOUR-CORNER FUSION PROCEDURES OWING TO WHAT HE REFERS TO AS LIMITED X-RAY INTERPRETATION OF FUSION. HE DID NOT VENTURE AN OPINION AS TO THE EFFICACY OR QUALITY OF THE ORIGINAL IMPLANT SURGERY TECHNIQUE EXPERIENCED BY THIS PT. IT WAS NOT REVEALED WHY THE ORIGINAL IMPLANTING SURGEON DID NOT PARTICIPATE IN THIS EXPLANT. CORRECTIVE/PREVENTIVE ACTION PLANNED: THE ROOT CAUSE OF THE PT'S PAIN APPEARS TO BE A COMBINATION OF INAPPROPRIATE BONE SCREW LENGTH SELECTION (WHICH RESULTED IN CARPAL JOINT IMPINGEMENT) AND/OR A BROKEN BONE SCREW, THE CAUSE OF WHICH WAS NOT ESTABLISHED. GIVEN THE (VERY) LIMITED INFO MADE AVAILABLE, NO CORRECTIVE OR PREVENTIVE ACTIONS CAN BE RECOMMENDED.

    Description of Event or Problem · 1

    ON 27 JULY, 2006, KINETIKOS MEDICAL, INC., WAS INFORMED OF THE EXPLANT OF A WRIST FUSION SYSTEM IMPLANT FROM A MALE PT TO ADDRESS PAIN. THE ORIGINAL IMPLANT DATE WAS NOT REPORTED, NOR WAS THE ORIGINAL IMPLANTING SURGEON IDENTIFIED. THE EXPLANTED COMPONENTS WERE NOT RETURNED TO KMI FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WRIST FUSION SYSTEM ORTHOPEDIC WRIST IMPLANT KWM KINETIKOS MEDICAL, INC. 07-5000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other