BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEASPINE SPACER SYSTEM

    MDR report key: 5110668 · Received September 29, 2015

    Report

    Report Number
    2032593-2015-00018
    Event Type
    Malfunction
    Date Received
    September 29, 2015
    Date of Event
    September 2, 2015
    Report Date
    March 31, 2016
    Manufacturer
    SEASPINE INC.
    Product Code
    MAX
    PMA / PMN Number
    K142488
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE REVIEW OF THE DHR, IT WAS CONCLUDED THAT THE PRODUCT WAS INSPECTED AND ACCEPTED FOR USE ON (B)(6) 2014 AND MET ALL SPECIFIED PARAMETERS OF THE RECEIVING INSPECTION REPORT WITH NO ASSOCIATED NONCONFORMANCE SPECIFIC TO THE PRODUCT ISSUE. THE IMPLANT WAS RECEIVED IN THREE PIECES, FRACTURED LATERALLY, MOST LIKELY AS A RESULT OF HAMMERING THE SIDE OF THE IMPLANT WITH THE PUSHER TO REPOSITION THE DEVICE LATERALLY ACROSS THE DISC SPACE. BASED ON A VISUAL INSPECTION OF THE DEVICES, THE FRACTURES APPEAR TO BE CONSISTENT WITH FRACTURE OF RIGID PLASTIC MATERIAL, WHICH CAN POTENTIALLY OCCUR IF THE DEVICE IS SUBJECTED TO LOAD OR IMPACT CREATING GREATER STRESS THAN THE MATERIAL CAN WITHSTAND. THE PROXIMAL INSERTION POINT IS INTACT AND DOESN'T APPEAR TO BE THE POINT OF IMPACT. DUE TO THE DAMAGE AREAS OF THE IMPLANT CANNOT BE MEASURED. THE AREAS THAT CAN BE MEASURED MET SPECIFICATIONS. THE ROOT CAUSE OF THE ISSUE IS UNKNOWN, BUT MAY BE THE RESULT OF SOME ACTION BY THE USER OR ANATOMICAL CONDITIONS OF THE PATIENT. PEEK IMPLANTS CAN FRACTURE AND MAY BE THE CONSEQUENCE OR RESULT OF IMPROPER SURGICAL TECHNIQUE (EXCESSIVE FORCE) OR INSUFFICIENT PATIENT DISC PREPARATION OR COLLAPSED DISC SPACE ALLOWING FOR PROPER INSERTION. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT. REVIEW OF LABELING NOTES: WARNING CAUTIONS AND PRECAUTIONS "LOOSENING, BENDING, DISLOCATION, AND/OR BREAKAGE OF THE COMPONENTS, POSSIBLY REQUIRING FURTHER SURGERY" "SURGICAL OUTCOMES WITH THIS DEVICE ARE SIGNIFICANTLY AFFECTED BY THE SURGEON'S PROPER PATIENT SELECTION, PREOPERATIVE PLANNING, PROPER SURGICAL TECHNIQUE, PROPER SELECTION AND PLACEMENT OF IMPLANTS AND COMPLETE COMPLIANCE OF THE PATIENT. SELECTION OF THE PROPER SIZE, SHAPE, AND DESIGN OF THE IMPLANT FOR EACH PATIENT IS EXTREMELY IMPORTANT AND CRUCIAL TO THE SUCCESS OF THE PROCEDURE. IMPLANTS ARE SUBJECT TO REPEATED STRESSES IN USE, AND THEIR STRENGTH IS LIMITED BY THE SIZE AND SHAPE OF THE HUMAN SPINE."

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE BROKE INTO FOUR PIECES DURING A SURGERY. THE IMPLANT WAS PLACED IN THE INTERBODY SPACE AT L4-5 AND THE INSERTER WAS REMOVED. THE IMPLANT THEN BROKE WHILE BEING POSITIONED WITH THE PUSHER DEVICE THAT COMES STANDARD IN THE SET. THE SURGEON STATED THAT THE IMPLANT WAS NOT IMPACTED VERY HARD AT ALL WITH THE PUSHER AND HE WAS SURPRISED THAT IT BROKE SO EASILY. THE BROKEN IMPLANT WAS REMOVED AND REPLACED WITH ANOTHER IMPLANT WITHOUT INCIDENT. THE SURGERY WAS DELAYED LESS THAN 10 MINUTES. THE PATIENT WAS NOT HARMED. THE BROKEN IMPLANT WAS SENT TO STERILE PROCESSING FOR CLEANING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642129 SEASPINE SPACER SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX SEASPINE INC. M019932E

    Patients

    Seq Age Sex Outcome Treatment
    1