BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR Ø1.3 SELF-TAP L11 TAN

    MDR report key: 2990310 · Received March 5, 2013

    Report

    Report Number
    1719045-2013-00433
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 4, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K112583
    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.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MEASURABLE DIMENSIONS COULD NOT BE CHECKED FOR ITS SPECIFICATION AS THERE WAS NO LOT NUMBER PROVIDED. UNFORTUNATELY ALSO THE SAME APPLIES FOR THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPER. THE INVESTIGATION SHOWS NO IRREGULARITIES. UNFORTUNATELY THE INFORMATION GIVEN DID NOT PROVIDE SUFFICIENT EVIDENCE FOR AN EXACT DETERMINATION OF THE FAILURE REASON. NEVERTHELESS, A MANUFACTURING RELATED CONDITION CAN BE EXCLUDED. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON (B)(6) 2013, THE SCREW HEAD SHEERED OFF DURING INSERTION. THE SCREW WAS REPLACED WITH ANOTHER SCREW WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94036 CORTSCR Ø1.3 SELF-TAP L11 TAN HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1