BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIX LOCKING CAP WITHOUT SADDLE

    MDR report key: 4519332 · Received February 16, 2015

    Report

    Report Number
    2520274-2015-10965
    Event Type
    Malfunction
    Date Received
    February 16, 2015
    Date of Event
    January 27, 2015
    Report Date
    January 27, 2015
    Manufacturer
    SYNTHES SELZACH
    Product Code
    NKB
    PMA / PMN Number
    PK120838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBERS REPORTED AS 9101701, 9133432, 9203287. THE EXACT LOT NUMBER IS NOT KNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    (LOT NUMBER): THE LOT NUMBER FOR THIS STERILE PART IS ONE OF TWO POSSIBLE STERILE LOT NUMBERS: 9101701 OR 9203287. (EXPIRY DATES): FOR LOT NUMBER 9101701 ¿ AUGUST 1, 2024. FOR LOT NUMBER 9203287 ¿ OCTOBER, 1, 2024. FOR LOT NUMBER 9101701 ¿ AUGUST 18, 2014. FOR LOT NUMBER 9203287 ¿ OCTOBER 20, 2014 DEVICE 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND.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 INFORMATION: PART WAS MANUFACTURED IN THE US UNDER THE ARTICLE NUMBER: 09.632.099 AND LOT NUMBER: 7762560. DHR REVIEW - MANUFACTURE DATE: 8-8-14. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON INSERTED 4 PEDICLE SCREWS AFTER HE INSERTED A CAGE BETWEEN VERTEBRAL BODIES, L4-L5. AFTER THAT, HE PLACED A ROD ON ONE SIDE BUT THE PATIENT¿S CONDITION TURNED TO WORSE ABOUT THAT TIME AND THE SURGERY WAS DISCONTINUED. THE PATIENT DECEASED THE NEXT DAY. IN THE SURGEON¿S OPINION, THE PATIENT¿S VEIN WAS DAMAGED DURING THE SURGERY WHICH CAUSED THE PATIENT¿S DEMISE. THIS REPORT IS 6 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111231 MATRIX LOCKING CAP WITHOUT SADDLE ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES SELZACH 9203287

    Patients

    Seq Age Sex Outcome Treatment
    1