BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX TOBRAMYCIN 1 PK

    MDR report key: 3840511 · Received May 30, 2014

    Report

    Report Number
    0002249697-2014-01975
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING SETTING TIME INVOLVING SIMPLEX BONE CEMENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. VISUAL INSPECTION AND FUNCTIONAL TESTING WAS COMPLETED ON THREE RETURNED SAMPLES OF THE REPORTED LOT. THE RESULTS WERE SATISFACTORY AND WITHIN SPECIFICATION. BMR REVIEW FOR THE SPECIFIED LOT INDICATES THAT THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. CHR REVIEW CONFIRMED ONE OTHER SIMILAR EVENT FOR THE REPORTED LOT. THE INVESTIGATION CONCLUDED THAT THE REPORTED SETTING TIME ISSUE CANNOT BE CONFIRMED. THE MIXING PROPERTIES OF THE RETURNED SAMPLES OF THE REPORTED LOT WERE TESTED AND SHOW THAT ALL REQUIRED SPECIFICATIONS ARE MET. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT THE CEMENT WAS HARDENING TO SLOW. THE HOSPITAL EXPERIENCED THAT THE CEMENT TOOK VERY LONG TIME TO HARDEN AND EVEN THOUGH THE MIXING WAS DONE THE RIGHT WAY THE CEMENT SEEM UNEVEN/UNEQUAL. PATIENT NR 2: THE CEMENT WAS 1 PORTION FROM THE CUPBOARD AT THE OR WITH LOT TLU062 . KEPT IN 21 DEGREES C + 1 PORTION (ANOTHER LOT) FROM THE STORAGE ROOM WHICH IS KEPT IN 21 DEGREES C. MIXED AS USUAL... HARDING TIME 17 MINUTES. CEMENT SEEM UNEVEN/UNEQUAL.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT THE CEMENT WAS HARDENING TO SLOW. THE HOSPITAL EXPERIENCED THAT THE CEMENT TOOK VERY LONG TIME TO HARDEN AND EVEN THOUGH THE MIXING WAS DONE THE RIGHT WAY THE CEMENT SEEM UNEVEN/UNEQUAL. PATIENT NR 2: THE CEMENT WAS 1 PORTION FROM THE CUPBOARD AT THE OR WITH LOT TLU062 . KEPT IN 21 DEGREES C + 1 PORTION (ANOTHER LOT) FROM THE STORAGE ROOM WHICH IS KEPT IN 21 DEGREES C. MIXED AS USUAL¿HARDING TIME 17 MINUTES. CEMENT SEEM UNEVEN/UNEQUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319477 SIMPLEX TOBRAMYCIN 1 PK IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH TLU062

    Patients

    Seq Age Sex Outcome Treatment
    1 Other