BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX SPINE SYSTEM

    MDR report key: 5852259 · Received August 5, 2016

    Report

    Report Number
    3004717358-2016-00002
    Event Type
    Malfunction
    Date Received
    August 5, 2016
    Date of Event
    July 7, 2016
    Report Date
    August 5, 2016
    Manufacturer
    SPINECRAFT
    Product Code
    NKB
    UDI-DI
    M8246000CR6001
    PMA / PMN Number
    K132603
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT INVESTIGATION WAS INITIATED FOR THE COMPLAINT PRODUCT. A REVIEW OF THE DHR AND OTHER RECORDS WAS CONDUCTED FOR THE COMPLAINT PRODUCT. THE RECORDS SHOWED THAT THE COMPLAINT PRODUCT WAS DESIGNED AND PRODUCED ACCORDING TO THE SPECIFIED MATERIAL AND MANUFACTURING & PRODUCTION PROCESSES. DISTRIBUTION RECORDS WERE ALSO REVIEWED. ALL ITEMS IN THIS LOT WERE STORED AND DISTRIBUTED IN ACCORDANCE WITH THE COMPANY'S APPROVED PROCEDURES. A TOTAL OF (B)(4) ITEMS IN THIS LOT WERE RECEIVED IN MAY OF 2012 AND A TOTAL OF (B)(4) HAVE BEEN USED IN SURGERIES SINCE THAT DATE WITHOUT ANY PROBLEM. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED. IF THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION, THEN A SUPPLEMENTAL REPORT WILL BE FILED WITH THE RESULTS.

    Additional Manufacturer Narrative · 1

    A PORTION OF THE SUBJECT PRODUCT WAS FINALLY RETURNED AND WAS VISUALLY INSPECTED. INSPECTION SHOWED THAT THE ROD BROKE CLOSE TO NOTCH CREATED DURING ROD BENDING WITH A FRENCH ROD BENDER. THE PRODUCT WAS ANALYZED FOR STRUCTURAL AND MATERIAL INCONSISTENCIES; FRACTURE MAY BE DUE TO BENDING FATIGUE. LESS EXTREME BENDING OF THE ROD IS ADVISED. THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE SUBJECT PRODUCT THAT COULD HAVE CONTRIBUTED TO THE REPORTED PROBLEM AND NO SYSTEMIC TRENDS REQUIRING IMMEDIATE ACTION HAVE BEEN OBSERVED. WE WILL MONITOR ANY EMERGING TRENDS.

    Description of Event or Problem · 1

    SURGEON PERFORMED THE FIRST STAGE OF A MULTI-STAGED POSTERIOR SURGERY ON (B)(6) 2016 TO TREAT A PATIENT WITH ADULT SCOLIOSIS. THE PATIENT UNDERWENT THE SECOND SURGERY ON (B)(6) 2016 TO COMPLETE THE TREATMENT. FOUR (4) MONTHS LATER THE PATIENT FELT A POP AND X-RAYS REVEALED A ROD FRACTURE ON THE RIGHT SIDE AT L5/S1. SHE NOW HAS PAIN. PATIENT IS SCHEDULED FOR A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502247 APEX SPINE SYSTEM COCR ROD NKB SPINECRAFT 62170 M8246000CR6001

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention