BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELINE

    MDR report key: 24462118 · Received February 26, 2026

    Report

    Report Number
    2031966-2026-00037
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Date of Event
    February 4, 2026
    Report Date
    February 26, 2026
    Manufacturer
    NUVASIVE, INC.
    Product Code
    OSH
    UDI-DI
    00887517551719
    PMA / PMN Number
    K143684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 6.0 RELINE SET SCREW FAILED WHILE BEING TIGHTENED DURING AN AIS SCOLI FUSION CASE WITH DR. JON ODA. DR. ODA WAS PROVISIONALLY TIGHTENING THE SET SCREW INTO A HOOK AT THE TOP OF THE CONSTRUCT WHEN HE INDICATED IT FELT STRANGE. UPON REMOVAL A LONG THREAD OF METAL HAD SHEARED OFF BUT WAS STILL ATTACHED TO THE SET SCREW. THIS EXTENDED SURGERY BY APPROX. 30 MINUTES AS THE DOCTOR ATTEMPTED TO REDUCE THE ROD TO THE HOOK AGAIN AND INSERT NEW SET SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567334 RELINE SPINAL BONE SCREW, NON-BIOABSORBABLE OSH NUVASIVE, INC. 13600000 00887517551719

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown