BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING HEAD SCREWSELF-TAPPING 75MM

    MDR report key: 4222158 · Received November 3, 2014

    Report

    Report Number
    9612488-2014-10468
    Event Type
    Injury
    Date Received
    November 3, 2014
    Report Date
    August 30, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    KTT
    PMA / PMN Number
    PK023941
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT DHR-CHECK WAS PERFORMED AND NO DISCREPANCIES COULD BE DETECTED. ALL RELEVANT KEY PARAMETERS WERE EVALUATED AND MET THE SPECIFICATIONS AND ALSO THE RESULT OF THE DHR- CHECK CONFIRMED TO THE REQUIRED MANUFACTURING PARAMETERS. THEREFORE THE COMPLAINT IS FROM MANUFACTURING- POINT OF VIEW RATED AS NOT VALID. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT ID: (B)(6). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREWS BROKE POST OPERATIVELY. A REVISION SURGERY WAS PERFORMED TO REMOVE THE DAMAGED PARTS. THIS IS REPORT NUMBER 1 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702139 5.0MM TI LOCKING HEAD SCREWSELF-TAPPING 75MM APPLIANCE,FIXATION,NAIL KTT SYNTHES BETTLACH 8026332

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention