BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOWERLOX

    MDR report key: 14178774 · Received April 21, 2022

    Report

    Report Number
    3006082533-2022-00002
    Event Type
    Injury
    Date Received
    April 21, 2022
    Date of Event
    March 22, 2022
    Report Date
    March 22, 2022
    Manufacturer
    CAPTIVA SPINE
    Product Code
    MNH
    PMA / PMN Number
    K180475
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    WHEN INVESTIGATION AND SUPPLEMENTAL INFORMATION IS AVAILABLE IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 0

    WHEN INVESTIGATION AND SUPPLEMENTAL INFORMATION IS AVAILABLE IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE PROVIDED. COMMUNICATION WITH SURGEON CONFIRMED THE FOLLOWING PATIENT DETAIL. A THIRD SURGERY WAS PERFORMED IN (B)(6) 2022 CONNECTING THE TWO SPINAL CONSTRUCTS AND EXTENDED UP A LEVEL. THE BROKEN IMPLANT SCREW PORTION OF PREVIOUS SURGERY WAS LEFT IN THE PATIENT, AND THE SURGEON WAS ABLE TO PLACE NEW IMPLANT SCREWS INTO THE SAME AFFECTED LEVEL. PATIENT SURGERY WAS COMPLETED AND NO FURTHER INFORMATION OR ANY PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    THE PHYSICIAN REPORTS PROGRESSIVE DEGENERATIVE SCOLIOSIS PATIENT DISCOVERED WITH (2) BROKEN EXT SCREWS AT UPPER CONSTRUCT LUMBAR LEVEL (L1) FROM PREVIOUS INSTRUMENTED FUSION PROCEDURE, DATED ON (B)(6) 2020, CLINICALLY PRESENTING WITH NON-UNION AT THE L1 LEVEL.

    Description of Event or Problem · 0

    THE PHYSICIAN REPORTS PROGRESSIVE DEGENERATIVE SCOLIOSIS PATIENT DISCOVERED WITH (2) BROKEN EXT SCREWS AT UPPER CONSTRUCT LUMBAR LEVEL (L1) FROM PREVIOUS INSTRUMENTED FUSION PROCEDURE, DATED 09/15/2020, CLINICALLY PRESENTING WITH NON-UNION AT THE L1 LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2327159 TOWERLOX CANULATED EXT SCREW MNH CAPTIVA SPINE 01190036
    2898817 TOWERLOX CANULATED EXT SCREW MNH CAPTIVA SPINE 01190036

    Patients

    Seq Age Sex Outcome Treatment
    1 Female TOWERLOX CANNULATED EXT SCREW| TOWERLOX CANNULATED EXT SCREW