BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-MESH ALT LG 6 DEG 40-56MM

    MDR report key: 3030961 · Received April 2, 2013

    Report

    Report Number
    1526439-2013-14774
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    November 29, 2010
    Report Date
    March 5, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    MQP
    PMA / PMN Number
    PK080568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAGE WAS LOST BY THE HOSPITAL AND IS NOT AVAILABLE FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO ISSUES IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD BE ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. NO DEFINITIVE MEDICAL EXPLANATIONS CAN BE MADE AS THE CAUSE OF THE CAGE BEING ¿UNDISTRACTED¿ AND THE CONCOMITANT DEVICE SET SCREW LOOSENING BASED ON THE INFORMATION PROVIDED. HOWEVER, THE PATIENT¿S BODY MASS INDEX (BMI) IS (B)(6) WHICH FALLS WITHIN ¿OVERWEIGHT¿ CATEGORY ON CHARTS AND THE PATIENT IS RELATIVELY YOUNG. ANOTHER POSSIBLE CONTRIBUTING FACTOR TO POOR (GENERAL) SURGICAL OUTCOME IN SPINAL FUSION IS THE HISTORY OF NICOTINE ABUSE AS WAS STATED IN PATIENT'S OPERATIVE REPORT. REVIEW OF THE COMPLAINT TREND ANALYSIS FOUND NO RELATED COMPLAINTS ASSOCIATED THIS PRODUCT CODE AND PRODUCTION LOT. THEREFORE, WITHOUT A PRODUCT SAMPLE, WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE, AND THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF THE COMPLAINT PRODUCT SAMPLE BECOMES AVAILABLE, THE COMPLAINT FILE WILL BE RE-OPENED AND PRODUCT EVALUATED.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. DEVICE WAS LOST IN THE HOSPITAL.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE HOSPITAL SENT AN AE REPORT TO (B)(4): PATIENT SUFFERED FROM FRACTURE OF L1. IMPLANTATION OF DISTRACTIBLE X-MESH CAGE WHICH WAS SPREAD AND SECURED WITH A SET SCREW. X-RAY AFTER SIX WEEKS SHOWED THE CAGE UNDISTRACTED. DURING REVISION SURGERY IT WAS NOTICED THAT THE SET SCREW HAD LOOSENED. THE CAGE WAS REMOVED AND WAS LOST AT THE HOSPITAL.

    Description of Event or Problem · 1

    CONCOMITANT DEVICE: UNKNOWN SET SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135279 X-MESH ALT LG 6 DEG 40-56MM SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP DEPUY SYNTHES SPINE 7243N

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention