BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE NANOPEEK

    MDR report key: 24713248 · Received March 30, 2026

    Report

    Report Number
    3009446038-2026-00001
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    March 3, 2026
    Report Date
    March 23, 2026
    Manufacturer
    NANOVIS SPINE LLC
    Product Code
    MAX
    UDI-DI
    00814216028280
    PMA / PMN Number
    K241605
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ATTEMPTED CONTACT WITH INITIAL REPORTER (B)(6) 2026 4:42PM CALLED (B)(6) - PER INFORMATION PROVIDED FROM THE MEDTRONIC PRODUCT EVENT SUMMARY REPORT ATTEMPTED CONTACT WITH INITIAL REPORTER (B)(6) 2026 11:29AM CALLED (B)(6) - FOLLOWED VOICE PROMPTS TO "RECORDS" AND LEFT A VOICE MESSAGE INITIAL REVIEW OF PRODUCT EVENT SUMMARY (B)(4) DETERMINED THE ADVERSE EVENT WAS NOT "CAUSED" BY THE IMPLANT. THE IMPLANT IS INTENDED TO BE USED WITH SUPPLEMENTAL FIXATION. THE SUPPLEMENTAL FIXATION OF 2 MEDTRONIC BONE SCREWS WERE LOOSENED AND BACKED OUT. CONTACTED MEDTRONIC REP. AND POST-OPERATIVE TRAUMA IS UNKNOWN, BONE QUALITY MEASURES BEFORE INITIAL IMPLANT WERE UNKNOWN, AND THE SAME SURGEON PERFORMED IMPLANT AND EXPLANT. INVESTIGATION DETAILS:THE ADAPTIX¿ PEEK INTERBODY SYSTEM WITH NANOTECHNOLOGY DEVICES AND THE CAPSTONE CONTROL¿ PEEK SPINAL SYSTEM WITH NANOTECHNOLOGY DEVICES INCLUDING THOSE WITH MACRO-, MICRO- AND NANO-ROUGHENED SURFACE TEXTURED FEATURES ARE INTENDED FOR SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY HISTORY AND RADIOGRAPHIC STUDIES) AT ONE OR TWO CONTIGUOUS SPINAL LEVELS FROM L2-S1. THESE PATIENTS SHOULD HAVE HAD SIX MONTHS OF NONOPERATIVE TREATMENT. THESE PATIENTS MAY HAVE HAD A PREVIOUS NON-FUSION SPINAL SURGERY AND/OR MAY HAVE UP TO GRADE 1 SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED SPINAL LEVEL(S). ADDITIONALLY, ADAPTIX¿ PEEK INTERBODY SYSTEM WITH NANOTECHNOLOGY AND THE CAPSTONE CONTROL¿ PEEK SPINAL SYSTEM WITH NANOTECHNOLOGY DEVICES CAN BE USED AS AN ADJUNCT TO FUSION IN PATIENTS DIAGNOSED WITH DEGENERATIVE SCOLIOSIS. THE ADAPTIX¿ PEEK AND THE CAPSTONE CONTROL¿ PEEK DEVICES ARE TO BE USED WITH AUTOGRAFT AND/OR ALLOGRAFT COMPRISED OF CANCELLOUS AND/OR CORTICOCANCELLOUS BONE GRAFT AND/OR DEMINERALIZED ALLOGRAFT BONE WITH BONE MARROW ASPIRATE. THESE IMPLANTS ARE INTENDED FOR USE WITH SUPPLEMENTAL FIXATION INDICATED FOR LUMBAR SPINAL FUSION PROCEDURES AND MAY BE IMPLANTED VIA AN OPEN OR A MINIMALLY INVASIVE POSTERIOR APPROACH AND/OR TRANSFORAMINAL APPROACH.

    Description of Event or Problem · 0

    INFORMATION PROVIDED FROM MEDTRONIC PRODUCT EVENT SUMMARY REPORT (B)(4) RECEIVED ON (B)(6) 2026: (B)(6) 2026 (B)(6) (REP, HCP): INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION SPINAL THERAPY AT L3/4 AND L4/5. IT WAS REPORTED THAT THE IMPLANT BACKED OUT AT THE L4/5 LEVEL. THERE WAS A LACK OF SOLID FUSION AT THE AFFECTED LEVEL. THE PATIENT WAS SCHEDULED FOR ADDITIONAL SURGERY TO REMOVE THE IMPLANT AT A LATER DATE. IT WAS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. (B)(6) 2026 (REP): ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURING REPRESENTATIVE THAT THE REVISION SURGERY PERFORMED ON (B)(6) 2026. PATIENT HAD LINGERING BACK PAIN POST OPERATIVELY. PATIENT HAD A PRE-OPERATIVE DIAGNOSIS OF LUMBAR RADICULOPATHY NEEDING A L3-L5 FUSION. (B)(6) 2026 (REP): ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURING REPRESENTATIVE THAT THE 2 SCREWS WERE LOOSENED AND THEY WERE EXPLANTED ON THE REVISION SURGERY PERFORMED ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775877 CAPSTONE NANOPEEK ADAPTIX PEEK INTERBODY WITH NANOTECHNOLOGY MAX NANOVIS SPINE LLC 74332410 MI179986 00814216028280

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention