BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEOPARD IMPLANT, PARALLEL, 28X

    MDR report key: 3950338 · Received July 22, 2014

    Report

    Report Number
    1526439-2014-11702
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    May 23, 2014
    Report Date
    July 2, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    MQP
    PMA / PMN Number
    PK031635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION NOTED THAT THE CAGE HAD BEEN FRACTURED INTO THREE (3) SOLID SEGMENTS. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DISCREPANCY WAS OBSERVED DURING THE MANUFACTURING PROCESS. PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. REVIEW OF THE COMPLAINT TREND ANALYSIS OF THE PRODUCT CODE FOUND NO EMERGING TREND. THE ROOT CAUSE OF THE CAGE BREAKING DURING SURGERY CANNOT POSITIVELY BE DETERMINED. HOWEVER, AS NOTED IN THE ACCOMPANYING INSTRUCTIONS FOR USE, EXCESSIVE TORQUE, WHEN APPLIED TO LONG-HANDLE INSERTION TOOLS, CAN CAUSE SPLITTING OR FRACTURE OF THE POLYMER/CARBON-FIBER IMPLANTS. WHEN A POLYMER/CARBON-FIBER IMPLANT IS IMPACTED OR HAMMERED INTO PLACE, THE BROAD SURFACE OF THE INSERTION TOOL SHOULD BE CAREFULLY SEATED FULLY AGAINST THE IMPLANT. IMPACTION FORCES APPLIED DIRECTLY TO A SMALL SURFACE OF THE IMPLANT COULD CAUSE FRACTURE OF THE IMPLANT. NO CORRECTIVE ACTION/PREVENTIVE ACTION IS NECESSARY AT THIS TIME AS THERE HAVE BEEN NO ISSUES IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. NO SYSTEMATIC TRENDS HAVE BEEN OBSERVED IN THIS COMPLAINT. THEREFORE, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE LEOPARD CAGE BROKE DURING TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SURGERY. THE SURGEON COMPLETED CASE WITH SAME/LIKE PRODUCT. THERE WAS NO SURGICAL DELAY AND NO REPORT OF ANY ADVERSE CONSEQUENCES TO THE PATIENT. ALL PIECES WERE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428833 LEOPARD IMPLANT, PARALLEL, 28X SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP DEPUY SYNTHES SPINE ANCCDD

    Patients

    Seq Age Sex Outcome Treatment
    1