BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVASIVE RELINE OPEN SYSTEM

    MDR report key: 15442596 · Received September 16, 2022

    Report

    Report Number
    2031966-2022-00183
    Event Type
    Injury
    Date Received
    September 16, 2022
    Date of Event
    April 16, 2021
    Report Date
    September 16, 2022
    Manufacturer
    NUVASIVE, INC.
    Product Code
    NKB
    UDI-DI
    00887517535078
    PMA / PMN Number
    K143684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TWO (2) CROSS-CONNECTORS WERE RETURNED TO NUVASIVE. IT IS UNKNOWN WHICH DEVICE MALFUNCTIONED INTRA-OPERATIVELY. LOT NUMBER N268872 OR N221994. DEVICE MSEP (B)(6) 2020 OR (B)(6) 2018 THE COMPLAINT DEVICES, TWO (2) CROSS-CONNECTORS AND ONE (1) 40IN-LB TORQUE HANDLE, WERE EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE EVALUATION IDENTIFIED THAT THE LOCKING CAMS ON BOTH CONNECTORS EXHIBITED SEVERE DEFORMATION TO THE HEXALOBE DRIVE FEATURES AS WELL AS DISLOCATION OF THE CAM COMPONENT IN THE ARM ASSEMBLIES. IT COULD NOT BE DETERMINED IF THE DAMAGE OCCURRED DURING THE REPORTED LOCKING FAILURE OF THE DEVICE OR DURING REMOVAL. HOWEVER, THE TORQUE HANDLE USED WITH THE FRACTURED DRIVER WAS DETERMINED TO BE DAMAGED AND OUT OF CALIBRATION, ALLOWING EXCESSIVE TORQUE FORCE TO BE APPLIED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO DISCREPANCIES WERE FOUND. THE CAUSE OF THE DEVICE FAILURES WAS DETERMINED TO LIKELY BE EXCESSIVE FORCE APPLIED BY THE DAMAGED HANDLE. LABELING REVIEW: "...POTENTIAL ADVERSE EVENTS AND COMPLICATIONS: POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: FRACTURE OF THE VERTEBRA..." "...WARNINGS, CAUTIONS AND PRECAUTIONS: THE IMPLANTATION OF SPINAL SYSTEMS SHOULD BE PERFORMED ONLY BY EXPERIENCED SPINAL SURGEONS WITH SPECIFIC TRAINING IN THE USE OF THIS SPINAL SYSTEM BECAUSE THIS IS A TECHNICALLY DEMANDING PROCEDURE PRESENTING A RISK OF SERIOUS INJURY TO THE PATIENT..." "...PRE-OPERATIVE WARNINGS: CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICE(S) AND INJURY TO THE PATIENT..." IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THAT PATIENT UNDERWENT AN INITIAL POSTERIOR FIXATION PROCEDURE. DURING THE PROCEDURE, AS THE SURGEON ATTEMPTED TO TIGHTEN THE LOCKING CAM OF THE CROSS CONNECTOR ON THE ROD, THE CAM SPUN AND WAS UNABLE TO BE TIGHTENED. SUBSEQUENTLY, THE SURGEON ENCOUNTERED DIFFICULTIES IN REMOVAL OF THE CONNECTOR AND HAD TO USE A LESKAL TO RIP THE DEVICE OUT OF THE CONSTRUCT, RESULTING IN A BROKEN PEDICLE. AS A RESULT, THE FUSION HAD TO BE EXTENDED. NO FURTHER PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126802 NUVASIVE RELINE OPEN SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB NUVASIVE, INC. 10060445 SEE H10 00887517535078

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Other TORQUE HANDLE, 40 IN-LB