BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALEO / VALEO II

    MDR report key: 9878041 · Received March 25, 2020

    Report

    Report Number
    3005032068-2020-00001
    Event Type
    Malfunction
    Date Received
    March 25, 2020
    Report Date
    March 10, 2020
    Manufacturer
    SINTX TECHNOLOGIES (FORMERLY AMEDICA CORP)
    Product Code
    MAX
    PMA / PMN Number
    K143518
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN VALEO OR VALEO II LUMBAR INTERBODY FUSION DEVICE. 510(K) IS K143518 AND PRODUCT CODE IS MAX. A COMPLAINT INVESTIGATION WAS INITIATED. THERE WERE NO CONSEQUENCES TO THE PATIENTS AFTER THE REPORTED SSIS OR ADVERSE EVENTS. THE PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION. PART AND LOT NUMBERS ARE UNKNOWN AND DEVICES WERE NOT RETURNED TO MANUFACTURER FOR ADDITIONAL REVIEW OR INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED NO CORRECTIVE OR PREVENTIVE ACTION IS PROPOSED. THE COMPLIANT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. THE DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING ARTICLE: CALVERT, G.C. ET.AL. CLINICAL OUTCOMES FOR LUMBAR FUSION USING SILICON NITRDE VS OTHER BIOMATERIALS. J SPINE SURG 2020. HTTP://DX.DOI.ORG/10.21037/JSS.2019.12.11. THE PURPOSE OF THIS STUDY WAS TO REVIEW OF LUMBAR FUSION OUTCOMES USING SILICON NITRIDE (SI3N4) CAGES (450 PATIENTS, 519 IMPLANTS) AT FOUR U.S. CENTERS. PREOPERATIVE PATIENT DEMOGRAPHICS, PAIN SCORES, COMORBIDITY DATA ALONG WITH POST-OPERATIVE LAST FOLLOW-UP. PAIN SCORES, COMPLICATIONS, ADVERSE EVENTS, AND SECONDARY SURGICAL INTERVENTIONS (SSI) WERE OBTAINED FROM CHART REVIEWS OF 450 PATIENTS WHO RECEIVED SILICON NITRIDE (VALEO/VALEO II) IMPLANTS. RESULTS WERE COMPARED TO LUMBAR FUSION REPORTED WITH OTHER BIOMATERIALS IN 26 COHORTS COMPRISED OF 1,025 PATIENTS, REPORTED IN 14 PUBLICATIONS. PATIENT FOLLOW-UP AVERAGED 11.4±9.8 MONTHS. PRE-OP DEMOGRAPHICS, COMORBIDITIES, AND VAS PAIN SCORES WERE COMPILED ALONG WITH LAST FOLLOW-UP PAIN SCORES, COMPLICATIONS, ADVERSE EVENTS, AND SSIS. AS A CONTROL GROUP, COMPARATIVE METADATA WERE COLLECTED FROM 26 PUBLICATIONS COMPRISING 14 COHORTS AND 1,025 PATIENTS. THE RESULTS DEMONSTRATED THAT IMPLANTED SI3N4 DEVICES WERE SAFE AND PROVIDED EQUIVALENT PAIN REDUCTION OUTCOMES TO OTHER COMMONLY USED SPACERS OR CAGES IMPLANTED UNDER DIFFERING SURGICAL APPROACHES. THE COMPLICATION RATE OF THE SI3N4 PATIENTS WAS ~9.8% COMPARED TO ~12.4% FOR THE METADATA (P=0.16). THE FOLLOWING COMPLICATIONS, ADVERSE EVENTS AND SSIS WERE REPORTED IN THE JOURNAL ARTICLE FOR SILICON NTRIDE IMPLANTS: RECURRENT SYMPTOMS 23; ADJACENT LEVEL DISEASE 11; SUBSIDENCE 3; WOUND INFECTION 3; MIGRATION OR NON-UNION [3]; AND HEMATOMA 1. SSIS WERE FOR ADJACENT LEVEL DISEASE 11; PERSISTENT PAIN ASSOCIATED WITH A PEDICLE SCREW 1; SCREW REMOVAL 1; AND SCREW REPOSITION 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345105 VALEO / VALEO II SPINAL IMPLANT - LUMBAR MAX SINTX TECHNOLOGIES (FORMERLY AMEDICA CORP) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other