BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Y-ADAPT-PL-2.4 SHAFT 8HO HE 3HO L56 TI

    MDR report key: 2890317 · Received December 29, 2012

    Report

    Report Number
    2520274-2012-04379
    Event Type
    Malfunction
    Date Received
    December 29, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 30, 2012
    Manufacturer
    SYNTHES USA,
    Product Code
    HRS
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION OF THE COMPLAINED ARTICLES SHOWS THAT THERE HAPPENED INDEED A WRONG LABELLING ON THE PACKAGE. STEPS HAVE BEEN TAKEN TO IMPROVE THE LABELING PROCESS.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED BY THE SALES CONSULTANT THAT, WRONG PACKAGE OF MATRIX MANDIBLE DCP 2 2HO T1.5 TI, 04.503.723 WAS IN A Y PLATE PACKAGE. CUSTOMER IDENTIFIED DIFFERENT PACKAGES WITH SAME ISSUE. THIS SAME PACKING MIX UP ISSUE WAS FOUND IN (B)(6) 2012 AND ALSO IN (B)(6). ADDITIONAL INFO PROVIDED FOUND THAT, LOT NO. 3373620 THAT WAS SEND IS NOT THE RIGHT ONE. PARTS HAVE NOT BEEN RECEIVED. THIS IS 1 OF 1 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Y-ADAPT-PL-2.4 SHAFT 8HO HE 3HO L56 TI Y PLATE HRS SYNTHES USA,

    Patients

    Seq Age Sex Outcome Treatment
    1 Y-ADAPT-PL-2.4 SHAFT 8HO HE 3HO L56 TI