BEUDAMED
    FDA Adverse Event Death Summary report: N

    PYRAMESH IMPLANT SYSTEM

    MDR report key: 10177470 · Received June 22, 2020

    Report

    Report Number
    1030489-2020-00683
    Event Type
    Death
    Date Received
    June 22, 2020
    Report Date
    June 22, 2020
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    EZX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. ALTHOUGH IT IS UNKNOWN WHETHER THE REPORTED SPINAL SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT DEATH, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PATIENT DEMOGRAPHICS: NO. OF PATIENTS - 9, GENDER- FEMALE (MALE- 4; FEMALE- 5), AGE (MEAN AGE) - 62 YEARS PROCEDURE INVOLVED: ACCF (ANTERIOR CERVICAL CORPECTOMY AND FUSION), ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF), PSF (POSTERIOR SPINAL FUSION), CORPECTOMY, ANTERIOR FIXATION A MULTI-CENTER RETROSPECTIVE OBSERVATIONAL STUDY WAS CONDUCTED TO OBTAIN POST-MARKET CLINICAL DATA FOR MEDTRONIC SPINE IMPLANTABLE DEVICES. THIS DATA WAS QUERIED AND GROUPED BASED ON THE SPECIFIC MEDTRONIC SYSTEM USED IN THE SURGICAL PROCEDURE AND ANALYZED TO ESTABLISH REAL-WORLD EVIDENCE (RWE) FOR THE PERFORMANCE AND SAFETY OF THE DEVICE IN QUESTION WHEN USED AS PART OF STANDARD CLINICAL PRACTICE. THIS DATA COLLECTION IS ONE PART OF ONGOING POST-MARKET CLINICAL SURVEILLANCE ACTIVITIES THAT ARE INTENDED TO CONFIRM AND MONITOR THE SAFETY AND PERFORMANCE OF THE DEVICE. THIS REPORT SUMMARIZES THE CLINICAL DATA OBTAINED BY MEDTRONIC AS PART OF THIS RETROSPECTIVE OBSERVATIONAL STUDY FOR THE PYRAMESH-C SPINAL SYSTEM (HEREAFTER REFERRED TO AS PYRAMESH-C). THE CLINICAL DATA SUMMARIZED IN THIS REPORT WERE EXTRACTED FOR ANALYSIS ON (B)(6) 2020. DATA OBTAINED AS PART OF THIS STUDY WAS PROVIDED TO IN A DE-IDENTIFIED FORMAT AND THEREBY PROVIDES NO PATIENT OR PRODUCT SPECIFIC IDENTIFIERS. IT WAS REPORTED IN THE CLINICAL TITLED ¿PYRAMESH-CTM SPINAL SYSTEM¿ THAT A TOTAL OF 9 PATIENTS MET THE MINIMAL INCLUSION CRITERIA OF HAVING A CLINICAL DIAGNOSIS AND DOCUMENTED SURGICAL IMPLANTATION OF PYRAMESH-C. BASED ON THE CHARTED DIAGNOSES, PATIENTS WERE STRATIFIED INTO ONE OF FOUR EVIDENCE GROUPS: TUMOR (2), DEGENERATIVE DISEASE (N = 5), TRAUMA (1), OR DEFORMITY (1). ON AN UNKNOWN DATE, POST-OP, 1 PATIENT FROM THE DEGENERATIVE DISEASE GROUP DIED. THE CAUSE OF DEATH AND TIMING IN RELATION TO THE SPINE SURGICAL PROCEDURE ARE UNKNOWN. OVERALL, WITHIN THIS LIMITED PATIENT POPULATION THE PYRAMESH-C SYSTEM PERFORMED AS EXPECTED, AND NO SAFETY RISKS WERE IDENTIFIED AS PART OF THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645648 PYRAMESH IMPLANT SYSTEM MESH, METAL EZX MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death