BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCORDE LIFT, LRD 9X23X8 MM

    MDR report key: 9117797 · Received September 25, 2019

    Report

    Report Number
    1526439-2019-52156
    Event Type
    Injury
    Date Received
    September 25, 2019
    Report Date
    August 29, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MAX
    UDI-DI
    10705034531946
    PMA / PMN Number
    K171425
    Removal / Correction Number
    Z-1226-2019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # ==> (B)(4). INVESTIGATION SUMMARY ==> IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CONCORD LIFT HAS MIGRATED ANTERIOR AND APPEARS TO HAVE COLLAPSED SOME FROM ITS INSERTION HEIGHT. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THE CONCORDE LIFT, LRD 9X23X8 MM, PRODUCT CODE: 197809123L, LOT NUMBER: 204548, QUANTITY 1, WAS NOT RETURNED TO THE CUSTOMER QUALITY UNIT FOR EVALUATION. THUS, AN INVESTIGATION WILL BE BASED ON A NO SAMPLE DEVICE EVALUATION. SHOULD MORE INFORMATION AND/OR THE DEVICE(S) BECOME AVAILABLE AT A LATER DATE, THIS COMPLAINT FILE WILL BE REOPENED AND THE DEVICE(S) WILL THEN RECEIVE A FULL EVALUATION. ALL COMPLAINT TRENDS WILL BE EVALUATED AS A PART OF THE DEPUY SPINE MONTHLY COMPLAINT REVIEW MEETING WITHOUT THE RETURN OF THE DEVICE(S), WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. NO CORRECTIVE ACTION/PREVENTIVE ACTION (CAPA) IS NECESSARY AT THIS TIME AS NO ISSUES WERE IDENTIFIED IN THE MANUFACTURING AND RELEASE OF THIS DEVICE(S) THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER SINCE THE LOT NUMBER WAS NOT IDENTIFIED. THEREFORE, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. SHOULD MORE INFORMATION AND/OR THE DEVICE(S)E BECOME AVAILABLE AT A LATER DATE, THIS COMPLAINT FILE WILL BE REOPENED AND THE DEVICE(S) WILL THEN RECEIVE A FULL EVALUATION. DEVICE HISTORY LOT ==> A REVIEW OF THE RECEIVING INSPECTION (RI) FOR CONCORDE LIFT, LRD 9X23X8 MM, WAS CONDUCTED .AS A RESULT, THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. 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 · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CONCORD LIFT HAS MIGRATED ANTERIOR AND APPEARS TO HAVE COLLAPSED SOME FROM ITS INSERTION HEIGHT. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914581 CONCORDE LIFT, LRD 9X23X8 MM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDOS INTERNATIONAL SàRL CH 204548 10705034531946

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention