BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK SCREW

    MDR report key: 7951169 · Received October 10, 2018

    Report

    Report Number
    3002806535-2018-01127
    Event Type
    Malfunction
    Date Received
    October 10, 2018
    Date of Event
    June 11, 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: 3002806535-2018-001126-1. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE REPORTED EVENT WAS CONFIRMED ON THE ASSOCIATED REPORT 3002806535-2018-001126-1.

    Description of Event or Problem · 0

    HIPLOC PLATE AND SCREW DOES NOT ASSEMBLE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS- STD BRL 4-HOLE PLATE 135 DEG , ITEM 2110-135-004, LOT 6187959. 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: 3002806535-2018-001126.

    Description of Event or Problem · 1

    HIPLOC PLATE AND SCREW DID NOT ASSEMBLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793144 UNK SCREW HWC BIOMET UK LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1