BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPINALPAK ASSEMBLY

    MDR report key: 12619516 · Received October 12, 2021

    Report

    Report Number
    0002242816-2021-00181
    Event Type
    Death
    Date Received
    October 12, 2021
    Date of Event
    September 23, 2021
    Report Date
    October 20, 2022
    Manufacturer
    EBI, LLC.
    Product Code
    LOF
    UDI-DI
    00812301020218
    PMA / PMN Number
    P850022
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE DEVICE NOT WAS RETURNED TO ZIMVIE FOR INVESTIGATION. THE REPORTED EVENT WAS NOT VERIFIABLE AFTER THE INVESTIGATION ASSOCIATED WITH SKIN IRRITATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. NO PHYSICAL AND/OR FUNCTIONAL CONDITION COULD BE FOUND AFTER THE DHR THAT COULD BE CONSIDERED A CAUSAL FACTOR FOR THE REPORTED COMPLAINT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY ZIMVIE WILL CONTINUE TO MONITOR FOR TRENDS. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT ADDED. D3: MANUFACTURER UPDATED. D10: DETAIL OF PRODUCT ADDED. G1-2: CONTACT OFFICE UPDATED. G3: DATE RECEIVED BY MANUFACTURER ADDED. G6: TYPE OF REPORT UPDATED. H2: FOLLOW UP TYPE ADDED. H3: DEVICE EVALUATED BY MANUFACTURER UPDATED TO NO. H4: DEVICE MANUFACTURER DATE ADDED. H6: DEVICE CODE UPDATED TO 2682 - PATIENT-DEVICE INCOMPATIBILITY. H6: INVESTIGATION CODE ADDED TO 3331 - ANALYSIS OF PRODUCTION RECORDS. H6: INVESTIGATION CODE ADDED TO 4116 ¿ INCOMPLETE DEVICE RETURNED. H6: INVESTIGATION CODE ADDED TO 4119 ¿ INSUFFICIENT INFORMATION AVAILABLE . H6: INVESTIGATION FINDINGS CODE ADDED TO 3221: NO FINDINGS AVAILABLE . H10: ADDITIONAL NARRATIVES/DATA . THE FOLLOWING SECTIONS HAVE BEEN CORRECTED: E3: OCCUPATION CORRECTED. H6: DEVICE CODE UPDATED TO 2993: ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). DATE OF EVENT: (B)(6) 2021. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE SALES REP. WHO STATED THE PATIENT'S SPINAL PAK WAS CAUSING EXTREME PAIN. HE'D LIKE TO RETURN IT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE SALES REP. WHO STATED THE PATIENT'S SPINAL PAK WAS CAUSING EXTREME PAIN. HE'D LIKE TO RETURN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1512760 SPINALPAK ASSEMBLY SPINALPAK STIMULATOR, NON INVASIVE LOF EBI, LLC. N/A N/A 00812301020218

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention SEE H10 NARRATIVE.