BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNESYS LIS, STABILIZING CORD, 200

    MDR report key: 8573379 · Received May 2, 2019

    Report

    Report Number
    0009613350-2019-00278
    Event Type
    Injury
    Date Received
    May 2, 2019
    Date of Event
    April 17, 2019
    Report Date
    July 26, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    NQP
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY INVESTIGATION RESULT. ADDITIONAL AND CORRECTED INFORMATION ARE FILLED IN THE FOLLOWING FIELDS: DHR REVIEW: 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: CORD RUPTURE. EVENT DESCRIPTION: IT WAS REPORTED THAT DURING STRETCHING THE DYNESYS LIS BAND 200 IT WAS RECOGNIZED THAT ABOVE THE L4 DYNESYS SCREW THE OUTER LAYER OF THE CORD WAS TORN A BIT. THEREFORE, THE TORN CORD WAS REMOVED AND A NEW ONE WAS APPLIED. THERE WAS NO IMPACT ON THE PATIENT BUT THERE WAS A DELAY OF ABOUT 45 MINUTES. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICE ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: THIS DEVICE IS INTENDED FOR TREATMENT. COMPATIBILITY: COMPATIBILITY CHECK COULD NOT BE PERFORMED AS ONLY ONE PRODUCT HAD BEEN REPORTED. CONCLUSION: NO PRODUCTS CONFIRMING THE REPORTED EVENT WAS RECEIVED. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. 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 AND NO EXACT ROOT CAUSE COULD 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

    PLEASE REFER TO REPORT 0009613350-2019-00278.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET WINTERTHUR AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET WINTERTHUR MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K031511. THE MANUFACTURER DID NOT RECEIVE THE DEVICE YET, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 THE OUTER LAYER OF A CORD WAS TORN A BIT. THEREFORE THE TORN CORD WAS REMOVED AND A NEW ONE WAS APPLIED. THE SURGERY WAS DELAYED BY 45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368718 DYNESYS LIS, STABILIZING CORD, 200 N/A NQP ZIMMER GMBH N/A 2854896

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R