BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7.5MM REVERE PEDICLE SCREW 50MM.

    MDR report key: 3131435 · Received May 10, 2013

    Report

    Report Number
    3004142400-2013-00009
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE PRODUCT WAS NOT RETURNED FOR EVAL HOWEVER A REVIEW WAS CONDUCTED OF ALL APPLICABLE MATERIAL RECORDS, MFG RECORDS, STORAGE RECORDS, AND DISTRIBUTION RECORDS ACCORDING TO THE DESCRIPTION OF THE PRODUCT USED WITH THE CONCOMITANT DEVICE. ALL RECORDS REVEALED ALL PRODUCT LOTS WERE MFG WITHIN SPECIFICATIONS, MAINTAINED AND DISTRIBUTED IN ACCORDANCE WITH ALL FEDERAL, STATE AND OPERATING PROCEDURES. SINCE THE SCREWS WERE NOT RETURNED FOR EVAL, WE ARE UNABLE TO DETERMINE THE EXACT CAUSE OF THE BREAK. IT WAS REPORTED THE PT HAD A FALL WHICH MAY HAVE CAUSED THE SCREWS TO BREAK OR THEY MAY HAVE FAILED IN TYPICAL FASHION AFTER FUSION HAD TAKEN PLACE OR A NON-UNION. EXACT IMPLANT DATE IS NOT KNOWN. IT WAS PERFORMED SOMETIME IN 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GLOBUS THAT A REVISION SURGERY TOOK PLACE (B)(6) 2013 TO REMOVE TWO BROKEN BILATERAL S1 SCREWS WHICH BROKE. BROKEN SCREWS WERE REPLACED WITH (2) 10.0MM REVERE PEDICLE SCREWS, 55MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209410 7.5MM REVERE PEDICLE SCREW 50MM. 7.5MM REVERE PEDICLE SCREW 50MM. NKB GLOBUS MEDICAL, INC. 124.476 (X2) NAL289XL (X2)

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention