BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOW PROFILE CROSSLINK SYSTEM

    MDR report key: 4878591 · Received June 30, 2015

    Report

    Report Number
    1030489-2015-01344
    Event Type
    Injury
    Date Received
    June 30, 2015
    Date of Event
    June 2, 2015
    Report Date
    August 10, 2015
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A PARENT ITEM WITH 510K# K032578 IS APPROVED FOR SALE IN US. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PRODUCT ANALYSIS:VISUAL REVIEW CONFIRMS IMPLANT FRACTURE. MICROSCOPIC EXAMINATION OF THE FRACTURE IDENTIFIED A MULTI-MODAL FAILU RE, WITH CONVEX STRIATIONS EVIDENT THROUGH MULTIPLE THREAD FLANK CROSS SECTIONS, WHICH ARE CONSISTENT WITH CYCLIC FATIGUE. THIS AREA IS SUBSEQUENTLY FOLLOWED BY RIVER LINES AND MORE SIGNIFICANT MATERIAL DISRUPTION, CONSISTENT WITH OVERLOAD. A SEARCH OF THE COMPL AINT DATABASE DID NOT IDENTIFY ANY ADDITIONAL COMPLAINT RETURNS WITH THIS PART/LOT# COMBINATION. UNABLE TO DETERMINE ROOT CAUSE DUE TO EVIDENCE WHICH COULD SUPPORT MULTIPLE CONCLUSIONS.

    Description of Event or Problem · 1

    INITIAL DIAGNOSIS: IDIOPATHIC SCOLIOSIS. IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR CORRECTION AND FUSION AT UNKNOWN THORACIC LEVELS. THE CROSSLINK (MULTI-SPAN) PLACED AT THE UPPER LEVEL WAS FOUND BROKEN AND HOOKS PLACED AT THE SAME LEVEL BILATERALLY WERE ALSO FOUND DISLOCATED, FOR WHICH A REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2015. THE PHYSICIAN REPORTED THAT, IN THE INITIAL SURGERY, THE CROSSLINK WAS PLACED BECAUSE, THE POSSIBILITY OF HOOK DISLOCATION WAS RELATIVELY HIGH. EXCESSIVE STRESS ON THE CROSSLINK PLATE WAS CONSIDERED AS THE CAUSE OF THE BREAKAGE. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2015. THE TWO RODS WERE CUT AT THE PLACE OF HOOK DISLOCATION AND A NEW CROSSLINK WAS PLACED UNDER 1 CM BELOW OF CUT PLACE. NO ADDITIONAL CORRECTION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423836 LOW PROFILE CROSSLINK SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0304250W

    Patients

    Seq Age Sex Outcome Treatment
    1 00013 YR Required Intervention