BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PEDICLE SCREW

    MDR report key: 151930 · Received February 23, 1998

    Report

    Report Number
    1818910-1998-00036
    Event Type
    Injury
    Date Received
    February 23, 1998
    Report Date
    January 29, 1998
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    MCV
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CO RECEIVED ADDITIONAL INFO THAT PROVIDED CO WITH THE CATALOG NUMBERS AND MFG LOT NUMBERS. CO HAS ALSO PROVIDED THE MFG DATE FOR THESE DEVICES. PART# 1741-11-000, LOT# 463790, MFR DATE 4/21/1993. PART#1741-17-000, LOT# 462130, MFR DATE 3/19/1993. PART# 1741-17-000, LOT# 462170, MFR DATE 3/23/1993. PART# 1741-17-000, LOT# 462230, MFR DATE 3/19/1993. PART# 1741-17-000, LOT# 462260, MFR DATE 3/19/1993. PART#1741-17-000, LOT# 462280, MFR DATE 3/19/1993. PART#1741-17-000, LOT# 462280, MFR DATE 3/19/1993. PART#1741-17-000, LOT# 462280, MFR DATE 3/19/1993. THE PRODUCTS WERE NOT RETURNED TO THE MFR FOR EVALUATION. IT IS STILL UNSURE WHICH PRODUCT WAS FRACTURED. THERE HAS BEEN NO ADDITIONAL INFO AS TO WHICH PART NUMBER FAILED. THEREFORE NO BASELINE WAS DONE. BASED ON THE PART NUMBERS, AN INITIAL BASELINE WAS DONE WITH THE PART NUMBERS ON 2/4/1997.

    Description of Event or Problem · 1

    COMPLAINANT CLAIMS A PORTION OF THE HARDWARE FAILED AND FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PEDICLE SCREW Implant SPINAL FIXATION DEVICE MCV DEPUY ORTHOPAEDICS, INC. NA SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention