BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTSCR Ø3.5 L22 SST

    MDR report key: 9520599 · Received December 26, 2019

    Report

    Report Number
    8030965-2019-71478
    Event Type
    Injury
    Date Received
    December 26, 2019
    Report Date
    December 5, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    UDI-DI
    07611819001541
    PMA / PMN Number
    K131186
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11: B1, B5, H1: THE INITIAL COMPLAINT WAS REVIEWED AND FOUND NOT REPORTABLE. IT WAS DETERMINED THIS COMPLAINT WAS A DUPLICATE OF A PREVIOUSLY REPORTED COMPLAINT AND WAS ALREADY REPORTED ON MANUFACTURER REPORT NUMBER 3009450884-2014-10038. 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 · 0

    THE INITIAL COMPLAINT WAS REVIEWED AND FOUND NOT REPORTABLE. IT WAS DETERMINED THIS COMPLAINT WAS A DUPLICATE OF A PREVIOUSLY REPORTED COMPLAINT AND WAS ALREADY REPORTED ON MANUFACTURER REPORT NUMBER 3009450884-2014-10038.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: HRS. INITIAL REPORTER OCCUPATION: SYNTHES EMPLOYEE. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT SYNTHES 1/3RD TUBULAR PLATE -STAINLESS STEEL-HEATING OF IMPLANT DURING MRI PROCESS. ALSO, PATIENT IS IN PAIN AFTER SURGERY. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS IS REPORT 5 OF 8 FOR PC-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313002 CORTSCR Ø3.5 L22 SST SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH 7740393 07611819001541

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention