BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR Ø2 SELF-DRILL L4 TAN

    MDR report key: 3101782 · Received May 9, 2013

    Report

    Report Number
    2520274-2013-02475
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    March 18, 2013
    Report Date
    April 15, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    MQN
    PMA / PMN Number
    K981275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    INVESTIGATION COORDINATED BY SYNTHES EUROPE. REPORT RECEIVED INDICATES AN INTACT SCREW WAS RECEIVED. BASED ON THE FACT THAT WE DID NOT RECEIVE ANY LOT NUMBER TO THIS ARTICLE WE ARE NOT ABLE TO PROVIDE A RELIABLE INVESTIGATION.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2013, A SCREW WAS TOO LOOSE AND NOT FIXED DURING THE OPERATION. IN ADDITION, IT WAS REPORTED THAT A DISEASED PART WAS FIXED WITH A 6MM SCREW INSTEAD OF A 4MM SCREW. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202942 CORTSCR Ø2 SELF-DRILL L4 TAN MQN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1