BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STD BRL LAG SCRW 12.5X120MM

    MDR report key: 7952438 · Received October 10, 2018

    Report

    Report Number
    3002806535-2018-01130
    Event Type
    Malfunction
    Date Received
    October 10, 2018
    Date of Event
    August 4, 2018
    Report Date
    March 6, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HWC
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3002806535-2018-001129-1. NO DEVICE PROBLEM FOUND. THE REPORTED EVENT WAS CONFIRMED ON THE ASSOCIATED REPORT 3002806535-2018-001129-1.

    Description of Event or Problem · 0

    HIPLOC PLATE AND SCREW DOES NOT ASSEMBLE.

    Additional Manufacturer Narrative · 1

    (B)(4). UDI - (B)(4). MEDICAL PRODUCT - STD BRL 4-HOLE PLATE 135 DEG, ITEM 2110-135-004, LOT 6224834. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3002806535-2018-001129.

    Description of Event or Problem · 1

    HIPLOC PLATE AND SCREW DID NOT ASSEMBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792977 STD BRL LAG SCRW 12.5X120MM HWC BIOMET UK LTD. 2017030215

    Patients

    Seq Age Sex Outcome Treatment
    1