BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERVICAL IMPLANT 16X14X7MM

    MDR report key: 2592974 · Received May 29, 2012

    Report

    Report Number
    3008657535-2012-00048
    Event Type
    Injury
    Date Received
    May 29, 2012
    Date of Event
    May 15, 2012
    Report Date
    May 29, 2012
    Manufacturer
    THEKEN SPINE LLC
    Product Code
    ODP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT A PT WHO PREVIOUSLY RECEIVED A THREE LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) WITH A COMPLETE CAGE USED AT EACH OF THE LEVELS, APPEARED ON X-RAY TO COLLAPSE. THE PT WAS SCHEDULED FOR REVISION SURGERY ON (B)(6) 2012 FOR CORPECTOMY WITH POSTERIOR FIXATION. INTEGRA HAS REQUESTED ADD¿L CLINICAL INFO. PRODUCT CATALOGUE NUMBERS THAT WERE EXPLANTED IN THIS COMPLETE CERVICAL IBD REVISION SURGERY WERE: 2 EACH 27-10-1607 IMPLANT 16X14X7MM, 6-DEG. ONE EACH 27-13-3514 SCREW, ST 3.5X14MM. FIVE EACH 27-14-3514 SCREW, SD 3.5X14MM. ONE EACH 27-10-1608 IMPLANT 16X14X8MM, 6 DEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CERVICAL IMPLANT 16X14X7MM COMPLETE ODP THEKEN SPINE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention