BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEBRAL BODY SET/SMALL- STERILE

    MDR report key: 12297871 · Received August 9, 2021

    Report

    Report Number
    8030965-2021-06539
    Event Type
    Malfunction
    Date Received
    August 9, 2021
    Date of Event
    July 12, 2021
    Report Date
    July 12, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWQ
    UDI-DI
    07611819471849
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE DEVICE HISTORY LOT: PART # 09.804.600S, SYNTHES LOT # J001643, SUPPLIER LOT # J001643, RELEASE TO WAREHOUSE DATE: 09 OCT 2020, EXPIRATION DATE: 01 SEP 2023, SUPPLIER: CONFLUENT MEDICAL TECHNOLOGIES. NR-0150979 WAS GENERATED DUE TO THE IDENTIFIED DEFECT TYPE: 0001426. THE 383 PIECES OF THIS LOT WITH ALL CORRECT LABELLING WILL BE RELEASED FROM HOLD. THE SINGLE NONCONFORMING PIECE WILL BE RETURNED TO THE SUPPLIER FOR DISPOSAL AS IS REQUIRED BY THE IMPORT FOR EXPORT PROCESS. DEVICE HISTORY REVIEW REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY OF PERCUTANEOUS VERTEBROPLASTY DUE TO TH12 CENTRUM FRACTURE. THE TRIAL BALLOON WAS INFLATED IN THE CENTRUM. WHEN TRIED TO RETRACT THE TRIAL BALLOON THROUGH THE SLEEVE, CONTRAST MEDIUM LEAKED FROM THE DAMAGED TRIAL BALLOON. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) UNK - SCREWS: DISTAL FEMUR. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192543 VERTEBRAL BODY SET/SMALL- STERILE APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ SYNTHES GMBH J001643 07611819471849

    Patients

    Seq Age Sex Outcome Treatment
    1