BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRA SPINE SYSTEM

    MDR report key: 12857199 · Received November 22, 2021

    Report

    Report Number
    3004717358-2021-00001
    Event Type
    Malfunction
    Date Received
    November 22, 2021
    Date of Event
    October 27, 2021
    Report Date
    November 22, 2021
    Manufacturer
    SPINECRAFT
    Product Code
    NKB
    UDI-DI
    00193082063169
    PMA / PMN Number
    K211323
    Removal / Correction Number
    NOT APPLICABLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE DEVICE WAS NOT RETURNED FOR EVALUATION TO SPINECRAFT AND WAS DISCARDED BY THE HOSPITAL, THE EXACT LOT NUMBER OF THE DEVICE USED COULD NOT BE RETRIEVED. ALSO, NO X-RAY IMAGES WERE MADE AVAILABLE TO SPINECRAFT FOR REVIEW. HOWEVER, BASED ON THE 6 LOT NUMBERS (204027, 206186, 101645, 111303, 154833 AND 180335) MANUFACTURED OF THE SAME SCREW SIZE THAT WERE IN THE KITS AVAILABLE WITH THE SURGEON AT THE TIME OF THIS SURGERY, THE REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR APPLICABLE MATERIAL, MANUFACTURING PROCESSES, DESIGN SPECIFICATIONS AND INSPECTION RECORDS. NO DEVIATIONS OR DISCREPANCIES WERE FOUND THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. FURTHERMORE, THE USAGE HISTORY REVIEW FOR THESE 6 LOTS SHOWED THAT A TOTAL OF (B)(4) SCREWS OUT OF THE (B)(4) MANUFACTURED FROM THESE LOTS HAVE BEEN USED IN DIFFERENT SURGERIES WITHOUT ANY REPORTED ISSUES. ALSO, A GENERAL REVIEW OF THE USAGE HISTORY OF ASTRA SYSTEM SCREWS AND COMPLAINT TREND ANALYSIS SHOWED THAT THOUSANDS OF THESE SCREWS HAVE BEEN USED IN SURGERIES SINCE THE LAUNCH OF THE SYSTEM IN 2015 IN THE US AND 2018 INTERNATIONALLY AND NO SCREW FRACTURES HAVE BEEN REPORTED TO DATE. BASED ON THE ABOVE INFORMATION, AND IN THE ABSENCE THE EXPLANTED SCREW OR ANY X-RAYS, NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED AS NO ISSUE HAS BEEN IDENTIFIED WITH THE DESIGN, MANUFACTURING OR RELEASE OF ANY OF THE SCREW LOTS WHICH MAY HAVE BEEN USED IN SURGERY THAT COULD HAVE CONTRIBUTED TO PROBLEM REPORTED. HOWEVER, TAKING INTO CONSIDERATION THE LEVEL OF SPINE AT WHICH THE SCREW SIZE SUBJECT TO THIS COMPLAINT (DIAMETER 5.5MM) WAS IMPLANTED (S1 LEVEL) AND THE TIME ELAPSED BETWEEN THE INITIAL SURGERY ((B)(6) 2021) & THE SCREW BREAKAGE NOTIFICATION ((B)(6) 2021), THE FOLLOWING POINTS WERE NOTED AS PROBABLE CONTRIBUTING FACTORS TO THIS FAILURE: 1. THE USE OF A DIAMETER 5.5MM SCREW AT S1 LEVEL FOR AN ADULT ANATOMY HAS NOT BEEN HEARD OF PRIOR TO THIS INSTANCE SINCE THE PEDICLE AT THAT LEVEL OF SPINE IS LARGE, NORMALLY REQUIRING SCREWS WITH LARGER DIAMETERS, AND THIS PART OF THE SPINE EXPERIENCES HIGHER LOADS AS COMPARED TO THE THORACIC / UPPER LUMBAR SPINE. FOR THIS REASON, TYPICALLY SCREW DIAMETERS OF 7.5 AND ABOVE ARE USED AT THE SACRO-ILIAC SPINE. BASED ON THIS, WE CAN ONLY POSTULATE THAT LOAD FORCE EXCEEDING THE LOAD CAPACITY OF THIS SCREW'S SMALLER DIAMETER WAS PROBABLY ENCOUNTERED POST-OP, CAUSING ITS SUBSEQUENT FAILURE. 2. POST-SURGERY, BONE FUSION IS EXPECTED TO OCCUR IN ABOUT 6 MONTHS. AND IN THIS CASE, SINCE THE ISSUE WAS IDENTIFIED AT APPROXIMATELY 8 MONTHS, THIS SCREW BREAKAGE LIKELY OCCURRED DUE TO NON-UNION AND CYCLICAL LOADING OVER TIME. THIS IS A KNOWN INHERENT RISK (WHICH IS SPECIFIED IN THE PRODUCT IFU) ASSOCIATED WITH METALLIC IMPLANTS WHERE IF BONY FUSION IS DELAYED, OR DOES NOT OCCUR, THE IMPLANT MAY EVENTUALLY BREAK DUE TO METAL FATIGUE

    Description of Event or Problem · 0

    APPROXIMATELY 8 MONTHS POST-OPERATIVELY, THE X-RAY IMAGES REVIEWED BY THE SURGEON REVEALED THAT ONE SCREW (DIAMETER 5.5X50MM) AT S1 LEVEL HAD FRACTURED. PATIENT CLINICAL SYMPTOMS ARE UNKNOWN. ALSO UNKNOWN ARE ANY CIRCUMSTANCES THAT MAY BE LINKED TO THE SCREW FRACTURE. THE ONLY KNOWN INFORMATION IS THE PATIENT ID, SURGEON NAME AND THE DATE OF INITIAL SURGERY, WHICH ALLOWED US TO RETRIEVE IMPLANTS RECORDS USED IN THAT SURGERY. THE PATIENT UNDERWENT A REVISION SURGERY TO REPLACE THE FRACTURED SCREW WITH A LARGER DIAMETER SCREW AND THE SURGERY WAS COMPLETED AS INTENDED WITH NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1753352 ASTRA SPINE SYSTEM SCREW NKB SPINECRAFT A5P-5550 00193082063169

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention A5S-T30