BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD, 480 MM

    MDR report key: 12847952 · Received November 19, 2021

    Report

    Report Number
    1526439-2021-02445
    Event Type
    Malfunction
    Date Received
    November 19, 2021
    Report Date
    October 26, 2021
    Manufacturer
    DEPUY SPINE INC
    Product Code
    NKB
    UDI-DI
    10705034077437
    PMA / PMN Number
    K111136
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL PRODUCT CODE: KWP;KWQ;MNH;MNI. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; 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 ON (B)(6) 2021, THE RODS WERE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES FIVE (5) NUMBER OF DEVICES. THIS REPORT IS FOR (1) ROD, 480 MM. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744977 ROD, 480 MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB DEPUY SPINE INC 179762480 BDH1FVN 10705034077437

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown EXP TI CP ROD, 300 MM| ROD, 300 MM| ROD, 300 MM| ROD, 480 MM