BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX SPINE SYSTEM

    MDR report key: 10698291 · Received October 19, 2020

    Report

    Report Number
    3004717358-2020-00003
    Event Type
    Malfunction
    Date Received
    October 19, 2020
    Date of Event
    September 21, 2020
    Report Date
    October 19, 2020
    Manufacturer
    SPINECRAFT
    Product Code
    NKB
    UDI-DI
    00193082004063
    PMA / PMN Number
    K132603
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON FEEDBACK FROM THE SALES REPRESENTATIVE AND AS DESCRIBED IN THE EVENT DESCRIPTION OF THIS REPORT, ABOUT 2.5 MONTHS POST THE ORIGINAL SURGERY, THE PATIENT CAME BACK IN DUE TO A FRACTURE AT THE L2 VERTEBRAL BODY AND WAS REVISED TO EXTEND THE CONSTRUCT UP TO T10. THEN APPROXIMATELY 3.5 MONTHS POST-OPERATIVELY, THE ORIGINALLY IMPLANTED RODS FRACTURED AT THE ROD CONNECTOR JUNCTION. THE PATIENT WAS REVISED AROUND 2 WEEKS AFTER THIS INCIDENT TO REPLACE THE FRACTURED RODS. ALTHOUGH THE RODS WERE NOT RETURNED TO SPINECRAFT AFTER THE REVISION SURGERY, THE LOT NUMBER OF THE FRACTURED RODS WAS CONFIRMED BASED ON THE ASSOCIATED DISTRIBUTION RECORDS. THE DEVICE HISTORY RECORD REVIEW CONDUCTED FOR THIS LOT (# 188244) PRESENTED NO DISCREPANCIES OR ANOMALIES. ADDITIONALLY, SINCE APEX AND ASTRA SYSTEM RODS ARE IDENTICAL AND USED INTERCHANGEABLY; THE REVIEW OF DHRS FOR 2 LOTS (164509 & 170059) FROM ASTRA FOR THE SAME ROD TYPE & SIZE MANUFACTURED USING THE EXACT SAME MATERIAL (HEAT NO. H27136) AS THE LOT RELATED TO THIS COMPLAINT SHOWED THAT ALL RECORDS WERE COMPLYING WITH SPINECRAFT SPECIFICATIONS AND ALL APPLICABLE REGULATORY REQUIREMENTS. THE USAGE HISTORY REVIEW FOR THE LOT RELATED TO THIS COMPLAINT SHOWED THAT 21 RODS FROM THIS LOT HAVE BEEN USED IN DIFFERENT SURGERIES TO DATE WITH NO ISSUES REPORTED. ALSO, A TOTAL OF 90 RODS FROM THE OTHER 2 LOTS HAVE BEEN USED TO DATE WITHOUT ANY ISSUES. FURTHERMORE, A GENERAL USAGE AND COMPLAINT HISTORY REVIEW FOR ALL 5.5MM AND 6.0MM DIAMETER TITANIUM DEFORMITY RODS FOUND ONLY ONE SIMILAR COMPLAINT FOR THIS ROD TYPE (TI DIAMETER 6.0MM) WHICH WAS CONJECTURED TO BE DUE TO EXCESSIVE CONTOURING OF THE ROD AND/OR DELAYED UNION AND CYCLICAL LOADING OVER TIME. LASTLY, THE POST-OPERATIVE X-RAY IMAGES RECEIVED WERE REVIEWED. THIS CONFIRMED THE ROD FRACTURE AT THE ROD CONNECTOR JUNCTION; HOWEVER, NO FURTHER CONCLUSIONS COULD BE MADE. BASED ON THE INFORMATION GATHERED AND REVIEWED, NO ISSUE WAS IDENTIFIED WITH THE DESIGN, MANUFACTURE OR RELEASE OF THIS LOT WHICH COULD HAVE CONTRIBUTED TO THE REPORTED PROBLEM. THEREFORE, NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED. HOWEVER, IT CAN ONLY BE ASSUMED THAT THE FOLLOWING FACTORS MAY HAVE CONTRIBUTED TO THIS FAILURE: DUE TO THE FRACTURE AT L2 VERTEBRAL BODY REQUIRING THE REVISION SURGERY (CONSTRUCT EXTENSION TO T10), LOAD APPLIED ON THE JUNCTION OF THE TWO CONSTRUCTS (L2-S2 AND L1-T10) WOULD HAVE BEEN GREATER THAN THE FORCES TYPICALLY ENDURED BY THESE IMPLANTS AS THE FRACTURE WOULD INTRODUCE CERTAIN INSTABILITY IN THE WHOLE CONSTRUCT. CONSIDERING THAT APPROXIMATELY 6 MONTHS HAD ELAPSED SINCE THE ORIGINAL SURGERY, SPINE LEVELS L3-S2 SHOULD HAVE STARTED TO FUSE, MAKING IT MORE RIGID COMPARED TO LEVELS L1-T10. THIS MAY HAVE LED TO ADDITIONAL FORCES BEING APPLIED ON THE ROD CONNECTOR JUNCTION BY THE EXTENDED CONSTRUCT FROM L1-T10. SINCE THE AXIAL CONNECTOR AND ROD COMBINATION IS MUCH STRONGER THAN THE RODS BY THEMSELVES, THERE WOULD BE A CHANGE IN STIFFNESS RIGHT AT THAT JUNCTION WHICH IN NORMAL SITUATIONS SHOULD NOT HAVE CAUSED THIS TYPE OF FAILURE. HOWEVER, DUE TO THE L2 FRACTURE AND PROBABLE FUSION OF L3-S2 LEVELS; THIS DIFFERENCE IN STIFFNESS COULD HAVE BEEN GREATER AND MAY HAVE LED TO THE ROD FRACTURE. LASTLY, BENDING, NOTCHING AND EXCESSIVE CONTOURING OF THE RODS DURING THE COURSE OF THE SURGERY MAY ALSO HAVE CONTRIBUTED TO THE REPORTED FAILURE. NO FURTHER INVESTIGATION IS ANTICIPATED. IN THE CASE THAT ANY RELEVANT ADDITIONAL INFORMATION BECAME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    THE PATIENT FIRST UNDERWENT A SURGERY WHERE A CONSTRUCT WAS PLACED IN SPINE LEVELS L2-S2. ABOUT 2.5 MONTHS POST-OPERATIVELY, THE PATIENT SUFFERED A FRACTURE AT L2 VERTEBRAL BODY (REASON FOR FRACTURE IS UNKNOWN) AND A REVISION SURGERY WAS PERFORMED TO EXTEND THE CONSTRUCT UP TO T10 SPINE LEVEL. DURING A ROUTINE PATIENT FOLLOW-UP APPROXIMATELY 3.5 MONTHS AFTER THIS REVISION-EXTENSION, X-RAY IMAGES REVEALED THAT THE TWO TI 5.5MM DIAMETER DEFORMITY RODS ORIGINALLY IMPLANTED HAD FRACTURED AT THE JUNCTION WHERE THE TANDEM ROD CONNECTORS WERE PLACED TO EXTEND THE CONSTRUCT TO T10. THE PATIENT WAS REVISED AROUND 2 WEEKS AFTER THIS INCIDENT TO REPLACE THE FRACTURED RODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1165409 APEX SPINE SYSTEM ROD NKB SPINECRAFT 5500-325D 188244 00193082004063

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention