BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH

    MDR report key: 4519345 · Received February 16, 2015

    Report

    Report Number
    3000270450-2015-10050
    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
    PK100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: (CATALOG NUMBER): THE ACTUAL COMPLAINANT PART FOR THIS REPORT IS THE STERILE PART WITH PART NUMBER 04.632.640S. (LOT NUMBER): THE LOT NUMBER FOR THE COMPLAINANT PART (STERILE) IS 9133432. THE ASSOCIATED NON-STERILE PART HAD A LOT NUMBER OF 7736660. THE MANUFACTURING DATE FOR THE COMPLAINANT PART (STERILE) WAS SEP 8, 2014. THE ASSOCIATED NON-STERILE PART WAS MANUFACTURED ON JULY 11, 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

    ADDITIONAL PRODUCT CODES FOR NON-STERILE PART: MNH, MNI, KWQ, KWP. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 NARRATIVE: LOT: 7736660. ADDITIONAL DHR INFORMATION: NON-STERILE PART - MANUFACTURE DATE: 7-11-14, PART WAS MANUFACTURED IN THE US: ARTICLE: 04.632.640. THE STERILE INFORMATION DOES NOT HAVE ANY CONNECTION TO THE REPORTED PROBLEM 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: 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.

    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 4 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110683 6.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES SELZACH 9133432

    Patients

    Seq Age Sex Outcome Treatment
    1