BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIANCE PEDICLE SCREW SYSTEM

    MDR report key: 19316016 · Received May 14, 2024

    Report

    Report Number
    3019837678-2024-00001
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Report Date
    June 25, 2024
    Manufacturer
    VY SPINE, LLC
    Product Code
    NKB
    PMA / PMN Number
    K081978
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    RELIANCE 7.5MM X 55MM POLYAXIAL SCREW, TI, IS PART OF THE RMS PEDICLE SCREW SYSTEM. VY SPINE WAS MADE AWARE OF THE BROKEN SCREW, (B)(6) 2024, VIA TEXT MESSAGE FROM FIELD REP FORREST SMITH. PHYSICIAN PERFORMED A REVISION (B)(6) 2024. SCREW HEAD WAS REMOVED AND THE EMBEDDED SCREW SHAFT WAS LEFT IN THE BONE PER PHYSICIAN. AT THIST TIME, IT IS UNKNOWN WHEN OR HOW THE SCREW BROKE.

    Description of Event or Problem · 0

    RELIANCE 7.5MM X 55MM POLYAXIAL SCREW, TI, IS PART OF THE RMS PEDICLE SCREW SYSTEM. VY SPINE WAS MADE AWARE OF THE BROKEN SCREW ON (B)(6) 2024, VIA TEXT MESSAGE FROM FIELD REP (B)(6). PHYSICIAN PERFORMED A REVISION ON (B)(6) 2024. SCREW HEAD WAS REMOVED AND THE EMBEDDED SCREW SHAFT WAS LEFT IN THE BONE PER PHYSICIAN. AT THIS TIME, IT IS UNKNOWN WHEN OR HOW THE SCREW BROKE. UPDATE: ORIGINAL PROCEDURE OCCURRED ON (B)(6) 2020. DURING THE REVISION A SCREW WAS PLACED ADJACENT TO THE BROKEN SCREW. THE BROKEN SCREW WAS DISCOVERED ON AN X-RAY DURING A FOLLOW-UP VISIT. THE PATIENT DID NOT REPORT ANY PAIN FROM BROKEN SCREW. PHYSICIAN REPORTED THE ROOT CAUSE AS PATIENT NON-COMPLIANCE TO POST OPERATIVE INSTRUCTIONS AS CAUSE OF THE BROKEN SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482636 RELIANCE PEDICLE SCREW SYSTEM 7.5X55MM POLYAXIAL SCREW, TI NKB VY SPINE, LLC 6P75055 11516-02

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Other