BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CALIX LUMBAR SPINAL IMPLANT SYSTEM

    MDR report key: 10802951 · Received November 6, 2020

    Report

    Report Number
    3005031160-2020-00027
    Event Type
    Injury
    Date Received
    November 6, 2020
    Date of Event
    September 24, 2020
    Report Date
    October 23, 2020
    Manufacturer
    XTANT MEDICAL
    Product Code
    MAX
    UDI-DI
    M697X0340241PCSTR1
    PMA / PMN Number
    K170119
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    X-RAY IMAGES THAT IDENTIFIED LOOSENING OF THE IMPLANT CONSTRUCT WERE NOT PROVIDED FOR THE COMPLAINT INVESTIGATION. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020. THERE WERE NO REPORTED COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THE REVISION PROCEDURE. ON 10/14/2020 A RESPONSE FROM THE COMPLAINANT, WHO IDENTIFIED THAT IN ADDITION A MIGRATED LOCKING CAP, THE SYSTEM ROD AND INTERBODY SPACER HAD MIGRATED RESULTING IN A PATIENT DURA TEAR. IT MAY BE POSSIBLE FOR A LOCKING CAP TO MIGRATE FROM THE ORIGINAL PROCEDURE IMPLANT CONSTRUCT LOCATION IF THE TORQUE APPLIED TO THE LOCKING CAP WAS NOT ENOUGH FOR APPROPRIATE FINAL LOCKING. THE COMPANY CONFIRMED THAT THE TORQUE LIMITING HANDLES THAT WERE USED DURING THE ORIGINAL PROCEDURE EFFECTIVELY LIMITED APPLIED TORQUE AS INTENDED. A LOCKING CAP COULD BECOME LOOSE AND MIGRATE IF THE IMPLANT CONSTRUCT WAS SUBJECTED TO INORDINATE STRESS PRIOR TO MATURATION OF THE FUSION MASS WAS CONFIRMED. THROUGH THE COURSE OF THE INVESTIGATION, THE COMPLAINANT ALSO REPORTED THAT THE SYSTEM ROD AND INTERBODY SPACER HAD MIGRATED RESULTING IN A PATIENT DURA TEAR. IF ANY COMPONENT OF AN IMPLANT CONSTRUCT BECOMES LOOSE, IT MAY ALLOW SHIFTING/LOOSENING OF OTHER IMPLANT COMPONENTS RESULTING IN IMPLANT MIGRATION. THE POTENTIAL COMPLICATIONS AND ADVERSE EFFECTS SECTION OF THE PEDICLE SCREW IFU INCLUDES EARLY OR LATE LOOSENING OF THE COMPONENTS; DISASSEMBLY, BENDING OR BREAKAGE OF ANY OR ALL OF THE COMPONENTS; NON-UNION (PSEUDARTHROSIS); AND DURAL TEARS. THE POTENTIAL COMPLICATIONS AND ADVERSE EFFECTS SECTION OF THE INTERBODY SPACER IFU INCLUDES EARLY OR LATE LOOSENING OF ANY OR ALL OF THE COMPONENTS; DURAL TEARS, PERSISTENT CSF LEAKAGE, MENINGITIS; NON-UNION (PSEUDARTHROSIS), AND DELAYED UNION, MAL-UNION.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED NOTIFICATION OF 9/24/2020 FROM A SURGICAL FACILITY, THAT REPORTED DURING A PATIENT'S ROUTINE EIGHT-MONTH FOLLOW-UP AN IMPLANT LOCKING CAP WAS IDENTIFIED AS HAVING MIGRATED SINCE THE ORIGINAL PROCEDURE. THE ORIGINAL L5-S1 DECOMPRESSION AND FUSION WITH PEDICLE SCREWS AND INTERBODY SPACER WAS PERFORMED ON (B)(6) 2020 DUE TO PERSONAL INJURY. THERE WERE NO KNOWN PATIENT COMPLICATIONS IDENTIFIED DURING THE ORIGINAL PROCEDURE. THE HEALTH STATUS OF THE PATIENT WAS REPORTED AS, "PATIENT'S GENERAL HEALTH IS WELL. HOWEVER, PATIENT IS EXPERIENCING GREAT PAIN WHEN STANDING, SITTING, AND WALKING." THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS SUBMISSION: 3005031160-2020-00023 AND 3005031160-2020-00026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265059 CALIX LUMBAR SPINAL IMPLANT SYSTEM INTERVERTEBRAL BODY FUSION DEVICE MAX XTANT MEDICAL X034-0241-PC-STR 061547 M697X0340241PCSTR1

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention