BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNESYS SPINE IMPL WIN GEN

    MDR report key: 13557070 · Received February 18, 2022

    Report

    Report Number
    0009613350-2022-00096
    Event Type
    Injury
    Date Received
    February 18, 2022
    Report Date
    June 6, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    NQP
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL PRODUCT: THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION.AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. UPDATED: H2, H6, H10. REPORTED EVENT: IT WAS REPORTED THAT 2 PATIENTS WERE RE-HOSPITALIZED DUE TO PLEURAL EFFUSION. AS NO PRODUCT WAS RETURNED, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE DONE AS THE LOT NUMBER WAS NOT AVAILABLE. NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. DEVICE IS USED FOR TREATMENT. INSUFFICIENT INFORMATION PROVIDED. UNABLE TO PERFORM A COMPATIBILITY CHECK. REVIEW OF COMPLAINT HISTORY COULD NOT BE DONE AS THE REFERENCE NUMBER WAS NOT AVAILABLE. MEDICAL RECORDS WERE NOT PROVIDED. THE INVESTIGATION DID NOT IDENTIFY A NONCONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE OR PREVENTIVE ACTIONS REQUIRED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO PATIENTS WERE RE-HOSPITALIZED DUE TO PLEURAL EFFUSIONPATIENT INVOLVED. DELAY UNKNOWN.

    Description of Event or Problem · 0

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527543 DYNESYS SPINE IMPL WIN GEN SPINE PROSTHESIS NQP ZIMMER SWITZERLAND MANUFACTURING GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SEE H10 NARRATIVE