BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNESIS HA PEDICLE+SET SCR 6.0X40

    MDR report key: 8427114 · Received March 16, 2019

    Report

    Report Number
    0009613350-2019-00142
    Event Type
    Injury
    Date Received
    March 16, 2019
    Date of Event
    February 20, 2019
    Report Date
    September 30, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    NQP
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. AS FOR ZIMMER SPECIALISTS TO PERFORM AN IN-DEPTH ANALYSIS IT IS REQUIRED TO HAVE ALL NECESSARY INFORMATION AT HAND, IT WAS THEREFORE TRIED SEVERAL TIMES TO RECEIVE ADDITIONAL INFORMATION FOR THIS CASE. THE MISSING INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE. DHR REVIEW: REF#: (B)(4). LOT#: 2921717 - YIELD: 48 - DELIVERED: 47 - SCRAPPED: 1 -1 PARTS SCRAPPED DUE TO COSMETIC DEFICIENCY THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TRIGGER CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: FUNCTIONAL : OTHER EVENT DESCRIPTION: IT WAS REPORTED THAT SURGEON HAS NOT IMPLANTED DEVICE BECAUSE THE VERTEBRAE DO NOT MOVE. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: - THIS DEVICE IS INTENDED FOR TREATMENT. - NO PRODUCT DOCUMENTATION WAS REVIEWED FOR INVESTIGATION. CONCLUSION SUMMARY: THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). BASED ON THE GIVEN INFORMATION THE COMPLAINT COULD NOT BE CONFIRMED. NATURE OF THE EVENT IS NOT CLEAR. NO IMPLANT PROBLEM CAN BE UNDERSTOOD FROM THE EVENT DESCRIPTION. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED EVENT. THEREFORE, AN EXACT ROOT CAUSE CANNOT BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY SURGEON NOT IMPLANTED THE DEVICE BECAUSE HE NOTICED THAT WAS NOT WORKING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219569 DYNESIS HA PEDICLE+SET SCR 6.0X40 N/A NQP ZIMMER GMBH N/A 2921717

    Patients

    Seq Age Sex Outcome Treatment
    1 Other