BEUDAMED
    FDA Adverse Event Other Summary report: N

    6.5MM REVERE PEDICLE SCREW 40MM

    MDR report key: 1027482 · Received April 7, 2008

    Report

    Report Number
    3004142400-2008-00002
    Event Type
    Other
    Date Received
    April 7, 2008
    Date of Event
    February 21, 2008
    Report Date
    March 31, 2008
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    MCV
    PMA / PMN Number
    K061202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE REPORT. A REVIEW WAS CONDUCTED ON ALL APPLICABLE MATERIAL RECORDS, MFG RECORDS, STORAGE RECORDS, AND DISTRIBUTION RECORDS. ALL RECORDS REVEALED THE PROD WAS MFG WITHIN SPECS, MAINTAINED AND DISTRIBUTED IN ACCORDANCE WITH ALL FEDERAL, STATE AND OPERATING PROCEDURES. THE SCREW WAS RETURNED FOR TEST AND EVAL. THE FIRST OBSERVATION IS THAT THE SCREW APPEARS TO HAVE BEEN DAMAGED UPON REMOVAL OF THE IMPLANT. THE REPORT STATES APPROX 11 MONTHS HAD ELAPSED FROM IMPLANTATION AND EVIDENCE OF A BREAKAGE. THERE ARE MANY PT FACTORS THAT CAN CONTRIBUTE TO A SCREW BREAKAGE DURING THIS TIME AND THE PACKAGE INSERT WARNS THAT "THE PT'S WEIGHT AND ACTIVITY HAVE AN EFFECT ON THE STRESSES OF THE IMPLANT" AND "PT'S ANATOMY SHOULD BE CONSIDERED WHEN SELECTING SCREW DIAMETER AND LENGTH." ADDITIONALLY, PUBLISHED STUDIES INDICATE THAT SCREWS UTILIZED IN THIS ANATOMICAL AREA HAVE FAILURE RATES AS HIGH AS 12.4%, "THE USE OF PEDICLE-SCREW INTERNAL FIXATION FOR THE OPERATIVE TREATMENT OF SPINAL DISORDERS," ROBERT W. GAINES JR, JBJS AM. 2000:82:1458; "COMPLICATIONS OF PEDICLE SCREWS IN LUMBAR AND LUMBOSACRAL FUSIONS IN 105 CONSECUTIVE PRIMARY OPERATION," P.C. JUTTE, R.M. CASTELEIN, EUR SPINE J, 2002011:594-598. BASED ON A RECORD REVIEW, TESTING, OBSERVATION, AND ALL AVAILABLE INFO, IT IS DETERMINED THAT THE REVERE PEDICLE SCREW DESIGN CONFORMS TO ALL APPLICABLE STANDARDS AND THERE WAS NO DEVIATION IN THE MFG PROCESS. THERE IS NO INDICATION THAT THE BREAKAGE WAS A RESULT OF PROD DEFECT, MALFUNCTION, OR POSES ANY INJURY WITH USE. ALL RECORDS PURPORT THE SCREW WAS OF THE HIGHEST QUALITY AND SAFETY.

    Description of Event or Problem · 1

    GLOBUS MEDICAL REC'D NOTIFICATION FROM A DIST, VIA A COMPANY PROCESSING/EVAL FORM, THAT A GLOBUS MFG SCREW HAD BROKEN AFTER IMPLANTATION. THE ONLY INFO REPORTED IS THAT A (B) (6) FEMALE PT HAD BEEN IMPLANTED ON (B) (6) 2007 WITH PEDICLE SCREWS AND A RADIOLUCENT SPACER IN THE L5-S1 DISC SPACE. THE SURGEON NOTICED A BROKEN SACRAL SCREW ON X-RAY DURING A POST-OPERATIVE VISIT. THE BROKEN SCREW WAS EXPLANTED ON (B) (6) 2008. IT WAS LATER CONFIRMED TO BE A 6.5 REVERE PEDICLE SCREW 40 MM AND RETURNED TO GLOBUS ON 03/15/08 FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.5MM REVERE PEDICLE SCREW 40MM PEDICLE SCREW MCV GLOBUS MEDICAL, INC. 124.464 GMG191NE

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other