BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSPACE TITANIUM PLIF IMPL.8° 7X7X22MM

    MDR report key: 6377995 · Received March 3, 2017

    Report

    Report Number
    9610612-2017-00063
    Event Type
    Malfunction
    Date Received
    March 3, 2017
    Date of Event
    January 31, 2017
    Report Date
    November 7, 2017
    Manufacturer
    AESCULAP IMPLANT SYSTEMS
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR ANY OTHER TECHNOLOGICAL CHARACTERISTICS WITH A MEDICAL DEVICE THAT IS REGISTERED WITHIN THE U.S. AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: JAPAN. IT WAS REPORTED THAT WHEN THE SURGEON WAS INSERTING THE CAGE DURING THE SURGERY THAT THE CAGE WAS BENT. THE SURGEON REMOVED THE CAGE BY USING ANOTHER INSTRUMENT TO SET IT IN PROPER POSITION. THE SURGEON FOUND THAT THE CRACK OF THE CAGE WHILE RE-INSERTING COULD NOT BE PERFORMED SMOOTHLY. THE PROCEDURE WAS COMPLETED BY USING A NEW CAGE AND THERE WAS NO HARM TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: USED TEST AND ANALYSIS EQUIPMENT: KEYENCE VHX 5000 DIGITAL MICROSCOPE. WE MADE A MICROSCOPIC INSPECTION OF THE IMPLANT INTERFACE. HERE WE FOUND ONE EDGE BENT AND ONE BENT BROKEN. THE EXTRACT OF THE DRAWING SHOWS THE TARGET STATE. BATCH HISTORY REVIEW: THE MANUFACTURING DOCUMENTS HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO SPECIFICATION VALID DURING THE TIME OF PRODUCTION. CONCLUSION AND ROOT CAUSE: THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USAGE RELATED. RATIONAL: WITHOUT FURTHER KNOWLEDGE ABOUT THE CIRCUMSTANCES WE ASSUME, THAT THE IMPLANT WAS NOT CORRECTLY APPLIED AT THE INSERTER AND OR HANDLED WITH TOO MUCH FORCE. NO CAPA IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159148 PROSPACE TITANIUM PLIF IMPL.8° 7X7X22MM IMPLANTS INTERBODY FUSION MAX AESCULAP IMPLANT SYSTEMS FJ274T 52053133

    Patients

    Seq Age Sex Outcome Treatment
    1 Other