BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ES2 INTEGRATED BLADE SCREW SIZE L 6.5X50MM

    MDR report key: 11088499 · Received December 29, 2020

    Report

    Report Number
    0009617544-2020-00212
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Date of Event
    December 1, 2020
    Report Date
    April 28, 2021
    Manufacturer
    STRYKER SPINE-US
    Product Code
    NKB
    UDI-DI
    07613327002195
    PMA / PMN Number
    K122845
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    G1 HAS BEEN CORRECTED FROM 'STRYKER SPINE-US' TO 'STRYKER SPINE-FRANCE. VISUAL, DIMENSIONAL, MATERIAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED.   DEVICE AND COMPLAINT HISTORY RECORDS REVIEW COULD NOT BE PERFORMED AS A VALID LOT CODE WAS NOT PROVIDED AND COULD NOT BE OBTAINED. IT WAS REPORTED THAT DURING REMOVAL OF THE SCREW, THE ES2 INTEGRATED BLADE SCREW SHAFT FRACTURED INTRA-OPERATIVELY. THE TIP OF THE SCREW WAS LEFT IN PATIENT. DUE TO LACK OF INFORMATION AND DEVICE NOT RETURNED, AN EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. POTENTIAL CAUSES INCLUDE: TOO MUCH FORCE APPLIED WHEN REMOVING CONSTRUCT MAY LEAD TO SCREW FRACTURE AND BROKEN FRAGMENT REMAIN IN PATIENT. H3 OTHER TEXT: DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING REMOVAL OF THE SCREW IN S1, THE ES2 INTEGRATED BLADE SCREW SHAFT FRACTURED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY; HOWEVER, THE TIP OF THE SCREW WAS LEFT IN THE PATIENT.

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REMOVAL OF THE SCREW IN S1, THE ES2 INTEGRATED BLADE SCREW SHAFT FRACTURED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY; HOWEVER, THE TIP OF THE SCREW WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1554406 ES2 INTEGRATED BLADE SCREW SIZE L 6.5X50MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB STRYKER SPINE-US 482804650 UNKNOWN 07613327002195

    Patients

    Seq Age Sex Outcome Treatment
    1