BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - CAGE/SPACERS: ACIS

    MDR report key: 10537972 · Received September 15, 2020

    Report

    Report Number
    8030965-2020-06997
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Date of Event
    August 18, 2020
    Report Date
    August 19, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    ODP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: G5-510K: THIS REPORT IS FOR AN UNKNOWN ACIS CAGE/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR 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 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 DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, THE CAGE CANNOT BE TIGHTENED ON THE ACIS INSERTER INSTRUMENT WHICH RESULTED IN A WOBBLE. THE CAGE WAS IMPLANTED EVEN THOUGH THE IMPLANT HOLDER WAS DEFECTIVE. NO REVISION REQUIRED. SURGERY COMPLETED SUCCESSFULLY WITHOUT ANY REPORTED DELAY. NO ADVERSE PATIENT HARM. CONCOMITANT DEVICES REPORTED: INNER SHAFT STD/LRG W/O STOP F/03.841.05 (PART # 03.841.059, LOT # T174656, QUANTITY 1); INNER SHAFT STD/LRG W/STOP F/03.841.050 (PART # 03.841.060, LOT # T171647, QUANTITY 1); ACIS IMPLANT INSERTER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1); INSERTION INSTRUMENT KNOB (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) UNKNOWN ACIS CAGE. THIS IS REPORT 3 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003187 UNK - CAGE/SPACERS: ACIS INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL ODP OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1