BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIS-C II CERVICAL STANDALONE SYSTEM

    MDR report key: 17612858 · Received August 24, 2023

    Report

    Report Number
    3008455034-2023-00012
    Event Type
    Malfunction
    Date Received
    August 24, 2023
    Date of Event
    August 7, 2023
    Report Date
    August 24, 2023
    Manufacturer
    GENESYS SPINE
    Product Code
    OVE
    PMA / PMN Number
    K191489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT WAS CLOSED JUNE 2, 2023 CONCLUDING THAT THE EVENT WAS NOT REPORTABLE TO THE FDA AS NO SERIOUS HARM OCCURRED TO THE PATIENT OR USER. ALTHOUGH STRYKER INFORMED GENESYS SPINE THAT A REVISION SURGERY WAS PLANNED FOR (B)(6), 2023, STRYKER DID NOT PROVIDE CONFIRMATION THAT THE REVISION HAD OCCURRED. BASED ON THE INFORMATION PROVIDED BETWEEN THE TIME OF GENESYS SPINE BEING MADE AWARE OF THE COMPLAINT (APRIL 18, 2023) AND THE CLOSURE DATE OF THE COMPLAINT (JUNE 2, 2023), THE ONLY REASONABLE CAUSE FOR THE ANCHORS TO HAVE BACK-OUT IS THAT THE USER DID NOT DEPLOY THE ANCHORS UNDER COMPRESSION TO THE INTERBODY DEVICE AND THE USER DID NOT VISUALLY CONFIRM THE ANCHORS WERE FULLY DEPLOYED AND COVERED BY THE LOCK AS OUTLINED IN THE GENESYS SPINE LC-055 3DP CERVICAL STANDALONE SYSTEM SURGICAL TECHNIQUE. THEN EVENT WAS RECORDED AS A USE ERROR. ON JULY 13, 2023 A REQUEST WAS RECEIVED FROM STRYKER FOR AN RMA NUMBER TO RETURN PARTS. STRYKER DID NOT INFORM GENESYS SPINE THAT A REVISION WAS PERFORMED AND IF SO WHEN. ON AUGUST 7, 2023, GENESYS SPINE RECEIVED 5 GAC-SM AIS-C CERVICAL STAND-ALONE, ANCHOR - SMALL FOR COMPLAINT (B)(4). COMPLAINT (B)(4) WAS REOPENED TO INVESTIGATE THE RETURNED ANCHORS. REVIEW OF THE RETURNED ANCHORS SHOWED NO SIGNS OF PRE-OPERATIVE DEFECTS. THE ANCHORS SHOWED SIGNS OF USE BUT NO SIGNS OF DAMAGE. ORIGINAL COMPLAINT CONCLUSION STATEMENT AND RISK ANALYSIS REMAINS AS THE ANCHORS SHOWED NO SIGNS OF CAUSATION FOR THE EVENT. REVISION SURGERY WAS PERFORMED AT AN UNKNOWN DATE. SINCE THE DATE OF THE REVISION SURGERY IS UNKNOWN, FOLLOWING FOLLOW-UP ATTEMPTS, THE EVENT AWARENESS DATE FOR GENESYS SPINE IS DOCUMENTED AS AUGUST 7, 2023. REPORTED TO THE FDA AUGUST 24, 2023.

    Description of Event or Problem · 0

    INITIAL COMPLAINT RECEIVED APRIL 18, 2023 STATED "ON (B)(6) SURGEON COMPLETED C4-6 ACDF USING AIS-C STAND-ALONE CAGE FOR THE FIRST TIME. INTRAOPERATIVE FINAL FILMS LOOKED GOOD AND SURGEON HAD NO CONCERNS. FOLLOWING WEEK ON (B)(6) WE REVIEWED POST-OP FILMS. ANCHOR LOOKED LIKE IT WAS COMING OUT OF THE CAGE AND NOT PROPERLY SEATED IN BODY OF BONE. CALLED GENESYS SENIOR PRINCIPALS TO DISCUSS CASE AND OUTCOME. SURGEON FOLLOWS UP ON WEEK OF 4/24 WITH PATIENT. ORDERED A CT AND X RAY TO CONFIRM ANCHOR IS NOT IN BONE.; REF#(B)(4) - COMPONENT: ANCHOR, LEVEL: C4, C5, C6. THIS WAS A 2 LEVEL ACDF C4-6. FEMALE PATIENT IN HER 30'S, SMALL STATURE AND WEIGHT. NO PREVIOUS SURGERIES PRIOR TO THIS PROCEDURE. CASE WAS COMPLETED SUCCESSFULLY AND IMPLANTS LOOKED TO BE PROPERLY DEPLOYED ON FINAL X-RAYS AND WITH DIRECT VISUALIZATION INTRA-OPERATIVELY." ON AUGUST 7, 2023, GENESYS SPINE RECEIVED 5 GAC-SM AIS-C CERVICAL STAND-ALONE, ANCHOR - SMALL. COMPLAINT WAS REOPENED TO INVESTIGATE THE RETURNED ANCHORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2114667 AIS-C II CERVICAL STANDALONE SYSTEM INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION OVE GENESYS SPINE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female