BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMOVABLE EXTENSION ARM-FLEX 30MM FOR CMF DISTRACTOR

    MDR report key: 10864153 · Received November 18, 2020

    Report

    Report Number
    2939274-2020-05218
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    October 22, 2020
    Report Date
    October 22, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    PBJ
    UDI-DI
    10887587015668
    PMA / PMN Number
    K170818
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PROCODE: MQN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J EMPLOYEE. (B)(4). 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

    IT WAS REPORTED THAT ON (B)(6) 2020, THE FLEXIBLE EXTENSION ARM WOULD NOT DISENGAGE FROM CMF DISTRACTOR BODY DURING DISTRACTION OSTEOGENESIS REMOVAL OF EXTENSION ARMS AFTER COMPLETION OF ACTIVATION PHASE. THE SURGEON TOOK THE PATIENT BACK INTO THE OPERATING ROOM TO REMOVE THE EXTENSION ARM ONLY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY REPORTED. THE PROCEDURE AND PATIENT OUTCOMES WERE UNKNOWN. THIS REPORT IS FOR ONE (1) REMOVABLE EXTENSION ARM-FLEX 30MM FOR CMF DISTRACTOR. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329645 REMOVABLE EXTENSION ARM-FLEX 30MM FOR CMF DISTRACTOR CRANIAL DISTRACTION SYSTEM PBJ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.315.125 10887587015668

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention