BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMEGALIF

    MDR report key: 7546811 · Received May 25, 2018

    Report

    Report Number
    1067095-2018-00001
    Event Type
    Injury
    Date Received
    May 25, 2018
    Date of Event
    April 18, 2018
    Report Date
    May 24, 2018
    Manufacturer
    SPINAL ELEMENTS
    Product Code
    MAX
    UDI-DI
    00840916124618
    PMA / PMN Number
    K150395
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE REVIEW OF DEVICE HISTORY RECORD, IT WAS CONCLUDED THAT THE PRODUCT WAS INSPECTED AND ACCEPTED FOR USE AND MET ALL SPECIFIED PARAMETERS WITH NO ASSOCIATED NONCONFORMANCES. NO INFORMATION ABOUT HOW OR IF THE DEVICE CAUSED OR CONTRIBUTED TO EVENT.

    Description of Event or Problem · 1

    AFTER RECEIVING OLIF SURGERY PATIENT REPORTEDLY HAD CONTINUED LEG PAIN. IT IS UNKNOWN IF THE SYMPTOMS WERE RECURRING OR NEW. IT IS UNKNOWN IT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. ORIGINAL SURGERY DATE WAS NOT GIVING AND DURATION OF IMPLANTATION IS UNKNOWN. REVISION SURGERY OCCUR ON (B)(6) 2018 AND THE IMPLANT WAS REMOVED AND DISCARDED. NO IMAGE OR FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388245 OMEGALIF LUMBAR INTERBODY FUSION DEVICE WITH BONE GRAFT MAX SPINAL ELEMENTS 72-00-092810-00 139856 00840916124618

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention