BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIRST DEVICE: 7.0MM REVERE DUAL OUTER DIAMETER

    MDR report key: 2865134 · Received May 20, 2010

    Report

    Report Number
    3004142400-2010-00014
    Event Type
    Injury
    Date Received
    May 20, 2010
    Date of Event
    April 21, 2010
    Report Date
    April 21, 2010
    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. A REVIEW WAS CONDUCTED OF ALL APPLICABLE MATERIAL RECORDS, MFG RECORDS, STORAGE RECORDS, AND DISTRIBUTION RECORDS. ALL RECORDS REVEALED THE PRODUCT WAS MANUFACTURED WITHIN SPECS, MAINTAINED, AND DISTRIBUTED IN ACCORDANCE WITH ALL FEDERAL, STATE AND OPERATING PROCEDURES. BASED ON RECORD REVIEW AND ALL AVAILABLE INFO, IT IS DETERMINED THE 7.0MM REVERE DUAL OUTER DIAMETER POLYAXIAL SCREW, 60MM DESIGN CONFORMED TO ALL APPLICABLE STANDARDS AND THERE WAS NO DEVIATION IN THE MANUFACTURE PROCESS. THERE IS NO INDICATION THAT THE ISSUE WAS A RESULT OF PRODUCT DEFECT OR MALFUNCTION. REF MFR REPORT: 3004142400-2010-00015 AND 00016.

    Description of Event or Problem · 1

    GLOBUS MEDICAL, INC RECEIVED NOTIFICATION FROM A SALES REP THAT GLOBUS MANUFACTURED SCREWS HAD BROKEN IN A PT AFTER IMPLANTATION AND WERE EXPLANTED. A MALE PT UNDERWENT ORIGINAL PLIF, L3-S1 SURGERY ON (B)(6) 2007 AND WAS IMPLANTED WITH A CONSTRUCT THAT INCLUDED REVERE DUAL OUTER DIAMETER POLYAXIAL SCREWS (DOD SCREWS) WITH CORRESPONDING RODS, ADJUSTABLE T-CONNECTOR, AND REVERE LOCKING CAPS. ON (B)(6) 2008, REVISION SURGERY OCCURRED ON THE PT BECAUSE THE RODS HAD SLIPPED OUT OF THE DOD SCREWS AND LOCKING CAPS AT S1. APPROX 26 MONTHS LATER, X-RAYS SHOWED THE PT HAD SOLID FUSION, BUT BOTH OF THE DOD SCREWS HAD BROKEN AT S1. REVISION SURGERY OCCURRED ON (B)(6) 2010 AND BOTH DOD SCREWS WERE REMOVED AND REVERE 8.5MM SCREWS WERE UTILIZED AT THE S1 LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST DEVICE: 7.0MM REVERE DUAL OUTER DIAMETER 7.0MM REVERE DUAL OUTER DIAMETER POLYAXIAL NKB GLOBUS MEDICAL, INC. 124.787 GMH230RA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SUSTAIN OBLIQUE SPACER| REVERE LOCKING CAPS| CP2 RODS| REVERE PEDICLE SCREWS| ADJUSTABLE T-CONNECTOR