BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEOPARD CAGE

    MDR report key: 3872771 · Received June 13, 2014

    Report

    Report Number
    1526439-2014-11613
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    MQP
    PMA / PMN Number
    PK031635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON USED AN INSERTER IN SET THAT THREADS INTO BACK OF THE CAGE IMPLANT. DURING IMPACTION, THE BACK HALF OF LEOPARD CAGE BROKE, LEAVING OTHER HALF OF THE DEVICE IN THE DISC SPACE. THE SURGEON RETRIEVED ALL OF THE BROKEN PIECES WITH A KOCHER INSTRUMENT AND INSERTED A SYNTHES OPAL CAGE. THE SAMPLE NOT BEING RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349901 LEOPARD CAGE SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 INSERTER, CATALOG NO. UNK