BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSPACE XP IMPLANT 0° 10X10.5X22MM

    MDR report key: 6609651 · Received June 2, 2017

    Report

    Report Number
    9610612-2017-00282
    Event Type
    Malfunction
    Date Received
    June 2, 2017
    Date of Event
    May 4, 2017
    Report Date
    July 12, 2018
    Manufacturer
    AESCULAP IMPLANT SYSTEMS
    Product Code
    MAX
    PMA / PMN Number
    K132421
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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: USA IT WAS REPORTED BY THE SURGEON THAT THE IMPANT RADIOGRAPHIC MARKERS COULD NOT BE VISUALIZED. THIS CAUSED AN INTRAOPERATIVE DELAY IN TRYING TO ASSESS THE LOCATION OF THE IMPLANT.

    Additional Manufacturer Narrative · 1

    AESCULAP INC. HAS INITIATED A RECALL OF THIS MATERIAL; 2916714-6/18/18-005R.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: NO PRODUCT AT HAND. 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 DESIGN RELATED. RATIONAL: THE TITANIUM X-RAY MARKERS ARE LESS RICH IN CONTRAST THAN TANTALUM MARKERS. BECAUSE OF THE TITANIUM COATING, THEY ARE MORE DIFFICULT TO OBSERVE. CORRECTIVE ACTION: A DESIGN CHANGE WAS IMPLEMENTED IN AUGUST 2014 (CHANGE NOTIFICATION 49909).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389581 PROSPACE XP IMPLANT 0° 10X10.5X22MM INTERBODY FUSION MAX AESCULAP IMPLANT SYSTEMS SO410P 51987600

    Patients

    Seq Age Sex Outcome Treatment
    1 Other