BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFORMITY, UNIPLANAR SCREW; SIZE 6.5X45 MM

    MDR report key: 9012025 · Received September 12, 2019

    Report

    Report Number
    3004774118-2019-00091
    Event Type
    Injury
    Date Received
    September 12, 2019
    Date of Event
    August 1, 2019
    Report Date
    September 16, 2020
    Manufacturer
    K2M, INC.
    Product Code
    NKB
    PMA / PMN Number
    K141873
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION: IT WAS OBSERVED THAT THE SHAFT OF THE UNI-PLANAR SCREW WAS FRACTURED IN HALF. THE DISTAL FRACTURED END WAS NOT RETURNED. DEVICE AND COMPLAINT HISTORY RECORDS WERE REVIEWED AND NO RELEVANT MANUFACTURING ISSUES OR SIMILAR COMPLAINTS WERE IDENTIFIED. ALTHOUGH THE ROOT CAUSE CANNOT BE DETERMINED DEFINITIVELY, IT IS POSSIBLE THAT PSEUDARTHROSIS MIGHT HAVE OCCURRED WHERE THE REPORTED SCREW WAS NOT ABLE TO ACHIEVE SPINAL FUSION. EVEN WITH SUCCESSFUL FUSION, THE IMPLANTED CONSTRUCT MIGHT HAVE BEEN SUBJECTED TO IRREGULAR DYNAMIC MOTION DURING THE PERIOD OF POST-OP, RESULTING IN THE SCREW FRACTURE AT THE SCREW/ROD INTERFACE.

    Additional Manufacturer Narrative · 0

    HAS BEEN CORRECTED FROM (B)(4) TO (B)(4).

    Additional Manufacturer Narrative · 0

    THE PRODUCT DETAILS HAVE BEEN UPDATED PER NEW INFORMATION RECEIVED. D3 AND G1 HAVE BEEN UPDATED FROM 'STRYKER SPINE- LEESBURG' TO 'K2M, INC.'

    Description of Event or Problem · 0

    THE PATIENT REPORTED PAIN 2 MONTHS POST-OPERATIVELY. IMAGING REVEALED THAT THE PEDICLE OF THE LEFT L5 WAS FRACTURED AND THE TULIP HEAD DETACHED FROM THE S1 SCREW. THE PATIENT WAS REVISED TO REMOVE THE FRACTURED SCREW.

    Description of Event or Problem · 0

    THE PATIENT REPORTED PAIN 2 MONTHS POST- OPERATIVELY. IMAGING REVEALED THAT THE PEDICLE OF THE LEFT L5 WAS FRACTURED AND THE TULIP HEAD DETACHED FROM THE S1 SCREW. THE PATIENT WAS REVISED TO REMOVE THE FRACTURED SCREW.

    Description of Event or Problem · 0

    THE PATIENT REPORTED PAIN 2 MONTHS POST-OPERATIVELY. IMAGING REVEALED THAT THE PEDICLE OF THE LEFT L5 WAS FRACTURED AND THE TULIP HEAD DETACHED FROM THE S1 SCREW. THE PATIENT WAS REVISED TO REMOVE THE FRACTURED SCREW.

    Additional Manufacturer Narrative · 1

    STATUS AND LOCATION OF THE DEVICE ARE CURRENTLY UNKNOWN.

    Description of Event or Problem · 1

    THE PATIENT REPORTED PAIN 2 MONTHS POST-OPERATIVELY. IMAGING REVEALED THAT THE PEDICLE OF THE LEFT L5 WAS FRACTURED AND THE TULIP HEAD DETACHED FROM THE S1 SCREW. THE PATIENT WAS REVISED TO REMOVE THE FRACTURED SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794991 DEFORMITY, UNIPLANAR SCREW; SIZE 6.5X45 MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB K2M, INC. GJCA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention