BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM

    MDR report key: 8156796 · Received December 12, 2018

    Report

    Report Number
    3007932279-2018-00001
    Event Type
    Injury
    Date Received
    December 12, 2018
    Date of Event
    June 20, 2018
    Report Date
    August 16, 2018
    Manufacturer
    RENOVIS SURGICAL TECHNOLOGIES
    Product Code
    OVD
    PMA / PMN Number
    K140106
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS REPORTED TO THE MEDWATCH PROGRAM (REPORT # MW5078247) ON (B)(4) 2018 BY THE AND OFFICIALLY RECEIVED BY THE FDA ON 7/3/2018. THE REPORTED DATE OF THE SURGERY ON THE MEDWATCH FORM IS (B)(6) 2017. RENOVIS REVIEWED SALES RECORDS FOR ALL ALIF CAGES USED IN SURGERIES ON THE REPORTED DATE. THERE WERE TWO TITANIUM ALIF SURGERIES COMPLETED ON (B)(6) 2017: THE FIRST WAS COMPLETED BY A SURGEON IN (B)(6). THE SURGEON REVIEWED THE PATIENT RECORD, INCLUDING AN MRI, AND STATED THAT THE CAGE IN HIS PATIENT HAS NOT FRACTURED. THE SECOND WAS COMPLETED BY A SURGEON IN (B)(6). MARKETING REACHED OUT TO THE SURGEON WHO ALSO REVIEWED THE PATIENT RECORD, INCLUDING AN MRI, AND STATED THAT THE CAGE IN HIS PATIENT HAS NOT FRACTURED. RENOVIS IS UNABLE TO IDENTIFY THE CAGE USED OR LOCATION OF SURGERY AS BOTH SURGEONS THAT IMPLANTED TITANIUM CAGES ON THE REPORTED SURGERY DATE HAVE STATED THAT THE CAGES IN THEIR PATIENTS HAVE NOT FRACTURED.

    Description of Event or Problem · 1

    RENOVIS RECEIVED MEDWATCH REPORT MW5078247 THROUGH THE U.S. MAIL ON 7/16/2018. PER THE MEDWATCH REPORT, A VOLUNTARY EVENT REPORT WAS RECEIVED FOR A "TESERA 3-D PRINTED ALIF CAGE." PER THE REPORT, THE "RENOVIS ALIF CAGE COULD NOT WITHSTAND NORMAL, AXIAL LOAD AND IN TURN, THE LATERAL ASPECT OF THE CAGE HAS FRACTURED AND IS COLLAPSED." THIS EVENT IS CLASSIFIED AS "SERIOUS INJURY" PER THE MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997966 S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM ANTERIOR LUMBAR INTERBODY FUSION SYSTEM OVD RENOVIS SURGICAL TECHNOLOGIES UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other