BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX SPINE SYSTEM

    MDR report key: 6777248 · Received August 9, 2017

    Report

    Report Number
    3004717358-2017-00002
    Event Type
    Malfunction
    Date Received
    August 9, 2017
    Date of Event
    July 10, 2017
    Report Date
    September 15, 2017
    Manufacturer
    SPINECRAFT
    Product Code
    NKB
    UDI-DI
    M8246000300D1
    PMA / PMN Number
    K132603
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO KNOWN INJURY TO THE PATIENT OR ANY LOSS OF THE DEFORMITY CORRECTION ACHIEVED DURING SURGERY. THE DEVICES INVOLVED WERE ALL MANUFACTURED BY SPINECRAFT AND MET SPECIFICATION REQUIREMENTS. COMPLAINT TREND ANALYSIS FOUND NO OTHER EARLY BREAKAGE COMPLAINTS TO HAVE BEEN REPORTED FOR Ø6.0 MM TITANIUM RODS. A REVIEW OF THE DEVICE HISTORY RECORD OF THE SPECIFIC LOT USED CANNOT BE COMPLETED WITHOUT LOT NUMBER INFORMATION SINCE THE DEVICE HAS NOT BEEN EXPLANTED. PROVIDED IMAGES WERE EXAMINED BUT NO CONCLUSIONS COULD BE MADE. BREAKAGE CAN OCCUR DUE TO DELAYED UNION OR NON-UNION AS WELL AS WITH CYCLICAL LOADING OF THE DEVICE OVER TIME. NOTCHES, SCRATCHES OR EXCESSIVE CONTOURING OF THE IMPLANT DURING THE COURSE OF SURGERY MAY ALSO CONTRIBUTE TO EARLY FAILURE. A FOLLOW UP REPORT WILL BE FILED IF A REVISION SURGERY IS PERFORMED AND ADDITIONAL INFORMATION OBTAINED.

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE EXPLANTS WERE NOT RETURNED FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE A DEFINITIVE CAUSE OF THE REPORTED EVENT. SEVERAL FACTORS MAY HAVE CONTRIBUTED TO THE RODS FRACTURE. THE LABELING WAS REVIEWED AND FOUND TO CONTAIN SUFFICIENT POST-OPERATIVE INSTRUCTIONS TO BE PROVIDED TO THE PATIENT. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE EXPLANTS ARE RETURNED. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT WILL BE FILED WITH THE RESULTS.

    Description of Event or Problem · 1

    APPROXIMATELY 3 MONTHS POST-OP, PATIENT EXPERIENCED A "POP" IN HER BACK AND COMPLAINED OF SOME DISCOMFORT. X-RAYS REVEALS THAT ONE OF THE Ø6.0 MM TITANIUM RODS IN THE LUMBAR REGION IS FRACTURED. HOWEVER, THERE WAS NO LOSS OF ALIGNMENT AND NO SUBSTANTIAL PAIN. AT THIS TIME, THERE IS NO REVISION SURGERY SCHEDULED, AND THE DEVICES REMAIN IMPLANTED. PATIENT WILL CONTINUE TO BE MONITORED BY THE SURGEON. IT IS REPORTED THAT REVISION SURGERY IS TO BE CONSIDERED IF THERE IS A LOSS OF ALIGNMENT DURING SUBSEQUENT FOLLOW UP VISITS.

    Description of Event or Problem · 1

    NO REVISION SURGERY WAS PERFORMED AFTER THE FIRST TITANIUM ROD BROKE. ABOUT 6 WEEKS LATER THE SECOND TITANIUM ROD BROKE. A REVISION SURGERY WAS PERFORMED AFTER THE SECOND ROD FRACTURED AND BOTH 6.0 MM TITANIUM RODS WERE REPLACED WITH 6.0 MM COCR RODS. THIS IS A FOLLOW UP REPORT FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557832 APEX SPINE SYSTEM ROD NKB SPINECRAFT 6000-300D UNKOWN M8246000300D1

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other A5P-7050| A5P-7050R