BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COCR DD ROD 3.5-5.5 X 600

    MDR report key: 12816510 · Received November 15, 2021

    Report

    Report Number
    1526439-2021-02417
    Event Type
    Malfunction
    Date Received
    November 15, 2021
    Report Date
    October 22, 2021
    Manufacturer
    DEPUY SPINE INC
    Product Code
    NKG
    UDI-DI
    10705034290331
    PMA / PMN Number
    K151885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PROCODE: KWP. (B)(6). THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COCR DD ROD 3.5-5.5 X 600 WAS BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A COCR DD ROD 3.5-5.5 X 600. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711058 COCR DD ROD 3.5-5.5 X 600 POSTERIOR CERVICAL SCREW SYSTEM NKG DEPUY SPINE INC 188310012 TBHGV 10705034290331

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown