BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW

    MDR report key: 16549558 · Received March 15, 2023

    Report

    Report Number
    2031966-2023-00046
    Event Type
    Injury
    Date Received
    March 15, 2023
    Date of Event
    December 7, 2022
    Report Date
    April 3, 2023
    Manufacturer
    NUVASIVE INC
    Product Code
    NKB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED NO RADIOGRAPHS WERE PROVIDED NO MATERIAL OR LOT NUMBER WERE PROVIDED IT IS UNKNOWN IF THIS WAS A NUVASIVE DEVICE THEREFORE THE COMPLAINT CANNOT BE CONFIRMED. IT IS UNKNOWN IF THE PATIENT EXPERIENCED A FALL OR HAD EXCESSIVE POST-OPERATIVE PHYSICAL ACTIVITY. PATIENT'S BONE QUALITY IS UNKNOWN. DUE TO A COMPLETE LACK OF INFORMATION PROVIDED NO INVESTIGATION CAN BE COMPLETED. NO MANUFACTURING OR LABELING REVIEW COULD BE COMPLETED AS IT IS UNKNOWN WHAT PRODUCT IT IS OR IF IT WAS A NUVASIVE DEVICE.

    Additional Manufacturer Narrative · 0

    MEDWATCH REPORT # 2031966-2023-00046 WAS INADVERTENTLY SUBMITTED. AFTER ADDITIONAL INFORMATION WAS RECEIVED AND REVIEWED ABOUT THE REPORTED EVENT IT HAS BEEN REPORTED THERE WAS NO INDICATION OF PRODUCT FAILURE, ADVERSE REACTION, DEATH OR SERIOUS INJURY OR THE NEED FOR INTERVENTION TO PREVENT SERIOUS INJURY SHOULD THIS OR A SIMILAR EVENT OCCUR. THE PATIENT WAS REVISED DUE TO SURGEON DESIRE TO CREATE MORE ANATOMICAL STABILITY AND IMPROVE OUTCOME. NO PRODUCT DEFICIENCY OR MALFUNCTION IDENTIFIED. NO REPORTABLE EVENT WAS IDENTIFIED AND THE ORIGINAL REPORTED EVENT MEDWATCH REPORT # 2031966-2023-00046 CAN BE REDACTED.

    Description of Event or Problem · 0

    ON DECEMBER 7, 2022 IT WAS REPORTED THAT A REVISION SURGERY WAS CONDUCTED TO REPLACE A 9.5X90 SCREW THAT CAME OUT POST-OPERATIVELY WITH A 10.5X90 BOLT. NO ADDITIONAL INFORMATION WAS GIVEN.

    Description of Event or Problem · 0

    ON (B)(6) 2022 IT WAS REPORTED THAT A REVISION SURGERY WAS CONDUCTED TO REPLACE A 9.5X90 SCREW THAT CAME OUT POST-OPERATIVELY WITH A 10.5X90 BOLT. ON (B)(6) 2023 THE REP STATED THAT THE SCREW DID NOT PULL OUT, BUT THE REVISION SURGERY WAS DUE TO THE PATIENT HAVING INSTABILITY WHICH LEAD THE SURGEON TO REVISE AND EXTEND THE CONSTRUCT AND UPSIZE THE PELVIC SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143264 UNKNOWN SCREW NKB NUVASIVE INC ASKU ASKU
    529039 UNKNOWN SCREW NKB NUVASIVE INC ASKU ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose D10000801