BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO PITUIT RNGR 2X6MM UP, BLK,180MM

    MDR report key: 5142170 · Received October 9, 2015

    Report

    Report Number
    2916714-2015-00907
    Event Type
    Malfunction
    Date Received
    October 9, 2015
    Date of Event
    August 11, 2015
    Report Date
    September 11, 2015
    Manufacturer
    CONTRACT MANUFACTURER: MERCED MEDICAL
    Product Code
    HTX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: ON-GOING. PRODUCT WILL NOT BE RELEASED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2015 DURING RIGHT MICROLUMBAR DISKECTOMY FOR HERNIATED NUCLEUS PULPOSUS L5-S1 (RIGHT) WITH RADICULOPATHY, THE MICRO PITUITARY WAS DISCOVERED TO HAVE A MISSING UPPER JAW WHEN IT WAS REMOVED FROM THE DISK SPACE. UNABLE TO LOCATE THE MISSING PIECE. FLUOROSCOPY WAS PERFORMED TO CONFIRM MISSING JAW NOT IN SURGICAL FIELD OR PATIENT. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO PATIENT INJURY. DEVICE WILL NOT BE RELEASED FOR EVALUATION. COMPLAINT NOT REPORTED TO AESCULAP, INC BY THE END-USER. INFORMATION RECEIVED VIA USER FACILITY MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670918 MICRO PITUIT RNGR 2X6MM UP, BLK,180MM RONGEURS HTX CONTRACT MANUFACTURER: MERCED MEDICAL MF449R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other