BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILLER, CALCIUM SULFATE PREFOR

    MDR report key: 6463696 · Received April 6, 2017

    Report

    Report Number
    2520274-2017-11211
    Event Type
    Injury
    Date Received
    April 6, 2017
    Report Date
    March 13, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT FOR DIAGNOSIS. A PROSPECTIVE, MULTI-CENTER CLINICAL AND RADIOGRAPHIC OUTCOMES EVALUATION OF CHRONOS STRIP FOR LUMBAR SPINE FUSION. JOURNAL OF CLINICAL NEUROSCIENCE, 25: 36-40. THIS REPORT IS FOR AN UNKNOWN CHRONOS STRIP (UNKNOWN QUANTITY/UNKNOWN LOT). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. (B)(4) NERVE ROOT IMPINGMENT, >5-DEGREE MOTION FLEXION AT 12 MONTHS IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: KANTER, A; ET AL (2015) A PROSPECTIVE, MULTI-CENTER CLINICAL AND RADIOGRAPHIC OUTCOMES EVALUATION OF CHRONOS STRIP FOR LUMBAR SPINE FUSION. JOURNAL OF CLINICAL NEUROSCIENCE, 25: 36-40. THIS PROSPECTIVE CLINICAL STUDY EVALUATED THE USE OF A COMPOSITE BONE VOID FILLER (CHRONOS STRIP, (B)(4)), COMBINED WITH BONE MARROW ASPIRATE PLUS LOCAL AUTOLOGOUS BONE, IN A SERIES OF PATIENTS UNDERGOING INSTRUMENTED POSTEROLATERAL SPINAL FUSION WITH INTERBODY SUPPORT. SEVENTY-SIX PATIENTS WERE ENROLLED AND TREATED PER PROTOCOL AT 13 CLINICAL SITES. AT 12 MONTHS, 65 OF 76 PATIENTS WERE EVALUATED, AND 61 OF 76 PATIENTS HAD FUSION RELATED DATA AVAILABLE FOR REVIEW; THE COMPOSITE RADIOGRAPHIC ENDPOINT WAS AVAILABLE FOR 71% OF THESE PATIENTS. AT 24 MONTHS, 55 OF 76 PATIENTS WERE EVALUATED, AND 52 OF 76 HAD FUSION RELATED DATA AVAILABLE FOR REVIEW; THE PRIMARY COMPOSITE RADIOGRAPHIC ENDPOINT WAS AVAILABLE FOR 49/76 PATIENTS. THE AVERAGE PATIENT WAS 50 YEARS OLD WITH A BODY MASS INDEX OF 29.9 KG/M2; 47.4% WERE MALE. SMOKERS COMPRISED 32% OF THE SAMPLE POPULATION. THE MAJORITY OF PATIENTS REPORTED PREOPERATIVE PAIN AFFECTING THE BACK, BUTTOCKS OR LEGS; 84.2% BEING PRESENT FOR GREATER THAN 1 YEAR. ALL PATIENTS UNDERWENT AT LEAST 6 MONTHS OF CONSERVATIVE CARE INCLUDING MEDICATIONS (NARCOTICS AND NON-STEROIDAL ANTI-INFLAMMATORY DRUGS), INJECTIONS, AND PHYSICAL THERAPY, AMONG OTHERS. MORE THAN HALF (55%) OF THE PATIENTS PRESENTED WITH SPINAL INSTABILITY. ONE ADVERSE EVENT WAS RELATED TO THE IMPLANTED HARDWARE: ON POST-SURGERY DAY 42, RADIOGRAPH IMAGING REVEALED THE HEAD OF A PEDICLE SCREW WAS DISCONNECTED. THIS EVENT DID NOT AFFECT TREATMENT OR CARE AND WAS UNRELATED TO THE CBVF. THE PATIENT WAS OBSERVED AND REQUIRED NO ADDITIONAL TREATMENT OR SURGERY, NOR WERE THERE CLINICAL SEQUELAE AT THE PATIENT¿S SUBSEQUENT 6, 12 OR 24 MONTH VISITS. SECONDARY SURGERY AT THE INDEX LEVEL OCCURRED IN THREE PATIENTS DUE TO WOUND INFECTION, NERVE ROOT IMPINGEMENT, AND CAGE MIGRATION. AT FINAL EVALUATION, 100% OF PATIENTS DEMONSTRATED SOLID POSTEROLATERAL HARDWARE POSITION WITHOUT RADIOGRAPHIC EVIDENCE OF TRANSLATION OR ANGULATION ON DYNAMIC IMAGING, AND 92.3% REVEALED SOLID BRIDGING BONE PER THE LENKE SCALE. ONE PATIENT HAD >5-DEGREE MOTION AT 12 MONTHS. THIS PATIENT WAS MISSING FLEXION/EXTENSION FILMS AT 24 MONTHS. THIS REPORT IS 2 OF 3 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN CHRONOS STRIP AND REFERS TO THE SERIOUS INJURY OF UNKNOWN PATIENTS WHO EXPERIENCED SECONDARY SURGERY DUE TO WOUND INFECTION, NERVE ROOT IMPINGEMENT AND >5-DEGREE MOTION FLEXION AT 12 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248039 FILLER, CALCIUM SULFATE PREFOR MQV SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention