BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK - CONSTRUCTS: EXPEDIUM POSTERIOR

    MDR report key: 21795728 · Received April 8, 2025

    Report

    Report Number
    1526439-2025-00482
    Event Type
    Death
    Date Received
    April 8, 2025
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. INVESTIGATION SUMMARY: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE 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 · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA) "DEPUY SPINAL IMPLANTS, SUBREPORT 2025 ¿ EXPEDIUM ANTERIOR" FROM SWEDISH SPINE REGISTRY (SWESPINE) REPORT. A TOTAL OF 35 PATIENTS WERE OPERATED WITH EXPEDIUM ANTERIOR INSTRUMENTATION BETWEEN JANUARY 02, 2006 AND DECEMBER 31, 2024. IN 4 CASES IT WAS COMBINED WITH EXPEDIUM POSTERIOR, IN 2 CASES WITH A NON-DEPUY DEVICE. ALL CASES ARE INCLUDED IN THE ANALYSIS. MEAN AGE OF THE PATIENTS WAS 20 YEARS. FEMALES WERE 60%. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED INCLUDE: REGISTERED INTRA-OPERATIVE (N=10): - (N=1) DEATH, - (N=3) DURAL INJURY, - (N=2) MEDULLARY INJURY, - (N=1) ROOT INJURY, - (N=3) OTHER. REGISTERED POST-OP COMPLICATIONS WITHIN 1 YEAR (N=3): - (N=2) SURGICAL SITE INFECTION, - (N=1) THROMBOSIS. REOPERATIONS (N=4): - (N=1) DRAIN HEMATOMA, - (N=1) REMOVAL IMPLANT, - (N=2) OTHER. THIS IS FOR THE UNKNOWN DEPUY EXPEDIUM ANTERIOR INSTRUMENTATION AND UNKNOWN DEPUY EXPEDIUM POSTERIOR INSTRUMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543372 UNK - CONSTRUCTS: EXPEDIUM POSTERIOR THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death