BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOD T20 DRIVER SHORT

    MDR report key: 5925133 · Received September 2, 2016

    Report

    Report Number
    1526439-2016-10636
    Event Type
    Malfunction
    Date Received
    September 2, 2016
    Date of Event
    August 9, 2016
    Report Date
    August 9, 2016
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    HWR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. SAMPLE NOT AVAILABLE.

    Description of Event or Problem · 1

    L4 PELVIC POSTERIOR SPINAL FUSION. TIP OF DRIVER HAS BURRED. SECOND DRIVER WAS USED, NO DELAY OR ADVERSE EVENT. THIS CASE IS NOT BEING REPORTED BY THE CUSTOMER, BUT JJM EMPLOYEE. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AS PART OF THIS REPORT; NO FURTHER INFORMATION WILL BE FORTHCOMING. NO DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575964 MOD T20 DRIVER SHORT DRIVER, PROSTHESIS HWR DEPUY SYNTHES SPINE GM4286001

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR