BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT DEFORMITY ROD, DUAL HEX; SIZE Ø5.5X500 MM, COCR

    MDR report key: 12941540 · Received December 6, 2021

    Report

    Report Number
    3004774118-2021-00381
    Event Type
    Malfunction
    Date Received
    December 6, 2021
    Date of Event
    November 22, 2021
    Report Date
    March 29, 2022
    Manufacturer
    K2M, INC.
    Product Code
    NKB
    UDI-DI
    10888857018495
    PMA / PMN Number
    K141873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL, DIMENSIONAL, MATERIAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. HOWEVER, X RAYS WERE PROVIDED SHOWING A FRACTURED ROD AND RAIL. CONSTRUCT WAS HEAVILY FIXATED ON ONE SIDE, WITH THE OTHER SIDE HAVING FIXATION AT THE TOP AND BOTTOM OF THE CONSTRUCT WITH ONLY 2 FIXATION POINTS IN-BETWEEN 8 LEVELS. FRACTURE OCCURRED AT THE APEX OF THE DEFORMITY CURVE ON THE LESS FIXATED SIDE, WHICH ALLOWED FOR A LARGE BENDING MOMENT TO EXIST WITHIN THE NON FIXATED REGION, WHICH CAN EVENTUALLY CAUSE A FATIGUE BREAKAGE OF THE ROD. DEVICE HISTORY RECORDS REVIEW COULD NOT BE PERFORMED AS A VALID LOT CODE WAS NOT PROVIDED AND COULD NOT BE OBTAINED. COMPLAINT HISTORY RECORDS WERE REVIEWED FOR THIS CATALOG, AND NO SIMILAR COMPLAINTS WERE IDENTIFIED. FROM THE PEDICLE SCREW SYSTEMS IFU: INTERNAL FIXATION DEVICES ARE LOAD SHARING DEVICES WHICH MAINTAIN ALIGNMENT UNTIL HEALING OCCURS. IF HEALING IS DELAYED OR DOES NOT OCCUR THE IMPLANT COULD EVENTUALLY BREAK, BEND OR LOOSEN. LOADS PRODUCED BY LOAD BEARING AND ACTIVITY LEVELS WILL IMPACT THE LONGEVITY OF THE IMPLANT. THE DEVICES WERE IMPLANTED FOR A PERIOD OF 18 MONTHS WITH A CONFIRMED NON UNION. THE CAUSE OF THE EVENT IS MULTIFACTORIAL WITH THE CONSTRUCT DESIGN ALONG WITH THE PATIENT'S NON UNION CONTRIBUTING TO THE EVENT. IT IS ALSO UNKNOWN IF THE PATIENT FELL OR WHAT THE PATIENT'S POST OP ACTIVITY LEVEL WAS, WHICH BOTH COULD HAVE CONTRIBUTED TO THE EVENT AS WELL.

    Additional Manufacturer Narrative · 0

    DEVICE REMAINS IMPLANTED IN PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MESA DEFORMITY STRAIGHT RAIL AND A DENALI DEFORMITY STRAIGHT ROD BROKE 18 MONTHS POST -OPERATIVELY. REVISION WILL BE PERFORMED, BUT HAS NOT BEEN SCHEDULED AT THIS TIME. THIS REPORT WILL CAPTURE THE DENALI DEFORMITY STRAIGHT ROD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MESA DEFORMITY STRAIGHT RAIL AND A DENALI DEFORMITY STRAIGHT ROD BROKE 18 MONTHS POST -OPERATIVELY. REVISION WILL BE PERFORMED, BUT HAS NOT BEEN SCHEDULED AT THIS TIME. THIS REPORT WILL CAPTURE THE DENALI DEFORMITY STRAIGHT ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1837184 STRAIGHT DEFORMITY ROD, DUAL HEX; SIZE Ø5.5X500 MM, COCR THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB K2M, INC. 111-B55500 10888857018495

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown