BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 7266688 · Received February 13, 2018

    Report

    Report Number
    3004024955-2018-00004
    Event Type
    Injury
    Date Received
    February 13, 2018
    Date of Event
    January 19, 2018
    Report Date
    September 5, 2018
    Manufacturer
    STRYKER SPINE-US
    Product Code
    MAX
    Removal / Correction Number
    Z-2786-2016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED VIA COMMUNICATION WITH THE SALES REPRESENTATIVE. VISUAL, DIMENSIONAL, FUNCTIONAL AND MATERIAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. X-RAYS, MEDICAL RECORDS AND CLINICAL HISTORY OF THE PATIENT WERE NOT PROVIDED FOR EVALUATION. MANUFACTURING HISTORY REVIEW AND COMPLAINT HISTORY REVIEW WAS NOT PERFORMED AS THE CATALOG AND THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. NO ADDITIONAL DETAILS WERE PROVIDED. IT WAS REPORTED THAT A REVISION SURGERY WAS PLANNED, HOWEVER IT WAS RESCHEDULED DUE TO HOSPITAL REASONS. THE NEW DATE IS UNKNOWN. NO ADDITIONAL INFORMATION REGARDING THE EVENT IS AVAILABLE AT THIS TIME THEREFORE A ROOT CAUSE OF THE CAGE MIGRATION CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED: THE CAGE WAS REMOVED IN OR ABOUT (B)(6) 2018.

    Description of Event or Problem · 0

    A PATIENT CONTACTED STRYKER SPINE TO OBTAIN INFORMATION ON AN IMPLANT THAT WAS CAUSING HIM PAIN. THE PATIENT IS PLANNED TO HAVE A REVISION SURGERY TO REMOVE THE IMPLANT. THE IMPLANT WAS REPORTED TO HAVE MIGRATED.

    Description of Event or Problem · 0

    A PATIENT CONTACTED STRYKER SPINE TO OBTAIN INFORMATION ON AN IMPLANT THAT WAS CAUSING HIM PAIN. THE PATIENT IS PLANNED TO HAVE A REVISION SURGERY TO REMOVE THE IMPLANT. THE IMPLANT WAS REPORTED TO HAVE MIGRATED.

    Additional Manufacturer Narrative · 1

    STRYKER SPINE SENT AN "URGENT RECALL LETTER AND PRODUCT ACCOUNTABILITY FORM" DATED JULY 26, 2016 TO ALL AFFECTED CUSTOMERS. FOR PATIENTS WHO HAVE HAD AN ACCULIF POSTERIOR LUMBAR (PL) EXPANDABLE INTERBODY IMPLANT, STRYKER SPINE IS RECOMMENDING ROUTINE CLINICAL AND RADIOGRAPHIC POST-OPERATED EVALUATION. SHOULD THE PATIENT REPORT ANY CHANGE IN OR DEVELOP NEAR-ONSET SYMPTOMS, MORE URGENT CLINICAL AND RADIOGRAPHIC EVALUATION SHOULD BE COMPLETED. THE PATIENT RECEIVED RECALL INFORMATION FROM THEIR SURGEON.

    Description of Event or Problem · 1

    A PATIENT CONTACTED STRYKER SPINE TO OBTAIN INFORMATION ON AN IMPLANT THAT WAS CAUSING HIM PAIN. THE PATIENT IS PLANNED TO HAVE A REVISION SURGERY TO REMOVE THE IMPLANT. THE IMPLANT WAS REPORTED TO HAVE MIGRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109236 UNKNOWN_SPINE_PRODUCT INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX STRYKER SPINE-US

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention