BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NANOSS 3D ADVANCED BONE GRAFT SUBSTITUTE

    MDR report key: 20999775 · Received December 23, 2024

    Report

    Report Number
    3009336436-2024-00002
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    April 12, 2022
    Report Date
    December 23, 2024
    Manufacturer
    XTANT MEDICAL, INC.
    Product Code
    MQV
    PMA / PMN Number
    K132050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS THE FIRST COMPLAINT OF THIS KIND FOR THE NANOSS 3D PRODUCT LINE. SUBSIDENCE INDICATES THAT THE PRODUCT HAS PACKED DOWN, INDICATING THAT THE PRODUCT MAY HAVE BEEN PACKED DOWN OR WASHED AWAY DURING USE. OTHER POTENTIAL CONTRIBUTING FACTORS COULD BE INADEQUATE GRAFT VOLUME, OR INADEQUATE RIGID FIXATION. BOTH OF THESE EVENTS ARE DOCUMENTED WITHIN IFU 430-000 "RADIOGRAPHIC ASSESSMENT OF THE DEFECT SITE PREOPERATIVELY IS ESSENTIAL TO ACCURATELY EVALUATE THE SHAPE AND VOLUME OF THE DEFECT. THIS ASSESSMENT AIDS IN TREATMENT PLANNING FOR APPROPRIATE PRODUCT SIZE AND PLACEMENT OF NANOSS 3D AND/OR INTERNAL FIXATION DEVICES" AND "STANDARD INTERNAL FIXATION TECHNIQUES SUCH AS THE USE OF PLATES AND/OR SCREWS MUST BE FOLLOWED TO OBTAIN RIGID STABILIZATION. NANOSS 3D DOES NOT POSSESS SUFFICIENT MECHANICAL STRENGTH TO SUPPORT THE REDUCTION OF A FRACTURE SITE PRIOR TO SOFT AND HARD TISSUE IN-GROWTH OR TO SUPPORT A LOAD. EXTERNAL STABILIZATION ALONE IS NOT SUFFICIENT TO ACHIEVE THE RIGIDITY NECESSARY FOR BONY IN-GROWTH OF THE NANOSS 3D MATERIAL. DO NOT USE NANOSS 3D TO GAIN SCREW PURCHASE OR TO STABILIZE SCREW PLACEMENT. SCREWS USED WITH NANOSS AND FIXATION DEVICES MUST ATTAIN RIGID FIXATION INTO THE HOST BONE." THE FAILURE MODE OF "FUNCTION (PRODUCT MIGRATES AWAY FROM GRAFT SITE)" EXISTS WITHIN THE RISK MANAGEMENT FILE FOR THE DEVICE AND "MIGRATION" IS IDENTIFIED AS A KNOWN CLINICAL RISK FOR THIS PRODUCEDURE. ADDITIONALLY, THE IFU COMMUNICATES "IMPLANT MIGRATION" AS A KNOWN RISK ASSOCIATED WITH THE PRODUCT LINE.

    Additional Manufacturer Narrative · 0

    BATCH NUMBER FOR THE PRODUCT COULD NOT BE IDENTIFIED, THEREFORE NO BATCH REVIEW COULD BE PERFORMED. NO OTHER DETAILS REGARDING THIS INVESTIGATION ARE AVAILABLE, HOWEVER THIS REPORT WILL BE UPDATED SHOULD THIS INFORMATION BECOME AVAILABLE AT A LATER DATE.

    Description of Event or Problem · 0

    DURING THE COMPILATION OF A CLINICAL REPORT ON (B)(6) 2024, THE FOLLOWING EVENT WAS IDENTIFIED: "PATIENT: (B)(6), DATE: ON (B)(6) 2023, EVENT: SUBSIDENCE OF THE GRAFT AT L3-L4." ADDITIONAL INFORMATION COMPILED REGARDING THIS EVENT: PRODUCT LINE: NANOSS 3D, DATE OF SURGERY: ON (B)(6) 2022, THE EVENT WAS INDICATED TO BE BOTH A "DEVICE ISSUE" AND A "PROCEDURE ISSUE" IN THE CLINICAL DATABASE. THE EVENTS DID NOT RESULT IN HOSPITAL STAY/ADMISSION, IMPAIRMENT OR DYSFUNCTION, DID NOT REQUIRE SURGICAL INTERVENTION, AND DID NOT REQUIRE OTHER INTERVENTION. AT THIS TIME, THE DEVICE REMAINS IN THE PATEINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85850 NANOSS 3D ADVANCED BONE GRAFT SUBSTITUTE BONE VOID FILLER MQV XTANT MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other