BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0MM TI CERVICAL SPINE LOCKING SCREW 16MM

    MDR report key: 2549479 · Received April 18, 2012

    Report

    Report Number
    1719045-2012-00347
    Event Type
    Injury
    Date Received
    April 18, 2012
    Report Date
    March 20, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    OVE
    PMA / PMN Number
    K073541
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    A PT WAS IMPLANTED WITH A ZERO-P IMPLANT FOR AN ACDF AT C3-4 AND C4-5 ON (B)(6) 2012. ONE OF THE ZERO-P GOING CAUDAL INTO C5 BACKED OUT OF THE IMPLANT BY A COUPLE OF MILLIMETERS. THE PT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 FOR THE HARDWARE REMOVAL. THE SURGEON REMOVED THE SCREW AT C4-5 AND DID NOT REVISE THE PT WITH A NEW SCREW. THE SURGEON DECIDED IT WAS BEST FOR THE PT TO NOT REPLACE THE SCREW. THIS REPORT IS #1 OF 2 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.0MM TI CERVICAL SPINE LOCKING SCREW 16MM 3.0MM TI CERVICAL SPINE LOCKING SCREW 16MM OVE SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention