BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZERO-P IMPLANT

    MDR report key: 2549486 · Received April 18, 2012

    Report

    Report Number
    2520274-2012-00637
    Event Type
    Injury
    Date Received
    April 18, 2012
    Report Date
    March 20, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    ODP
    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 #2 OF 2 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERO-P IMPLANT ZERO-P IMPLANT ODP SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention