BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHESAPEAKE® STABILIZATION SYSTEM

    MDR report key: 8163872 · Received December 14, 2018

    Report

    Report Number
    3004774118-2018-00183
    Event Type
    Injury
    Date Received
    December 14, 2018
    Date of Event
    September 17, 2018
    Report Date
    November 20, 2018
    Manufacturer
    K2M. INC
    Product Code
    OVD
    PMA / PMN Number
    K145487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE SUBJECT IMPLANT AND ASSOCIATED SURGICAL EQUIPMENT WAS NOT AVAILABLE FOR EVALUATION. A REVIEW OF REPORTED STERILIZATION SPECIFICATIONS DID NOT REVEAL ANY DISCREPANCIES. A CORRELATION BETWEEN THE INTERBODY AND THE INFECTION COULD NOT BE MADE.

    Description of Event or Problem · 0

    ON (B)(6) 2018 IT WAS REPORTED TO K2M, INC THAT A PATIENT DEVELOPED AN INFECTION POST-OPERATIVELY.

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE SUBJECT PRODUCT WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS STILL IN PROCESS. WHEN INVESTIGATION IS COMPLETE, K2M INC. WILL FILE A SUPPLEMENTAL REPORT INDICATING THE FINDINGS.

    Description of Event or Problem · 1

    ON (B)(6) 2018 IT WAS REPORTED TO K2M, INC. THAT A PATIENT DEVELOPED AN INFECTION POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006572 CHESAPEAKE® STABILIZATION SYSTEM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT OVD K2M. INC FKLP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other