BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5MM TI CANN COMPRESSION HEADLESS SCREW LT 70MM

    MDR report key: 12188893 · Received July 19, 2021

    Report

    Report Number
    3012966183-2021-00016
    Event Type
    Malfunction
    Date Received
    July 19, 2021
    Date of Event
    June 8, 2021
    Report Date
    July 19, 2021
    Manufacturer
    TYBER MEDICAL
    Product Code
    HWC
    PMA / PMN Number
    K192975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS RECEIVED ON (B)(6) 2021 SENT BY THE COMPLAINANT ON (B)(6) 2021. THE DATE OF AWARENESS WAS (B)(6) 2021 ACCORDING TO THE REPORT. THE LOT IS UNKNOWN. A HISTORICAL DATA REVIEW WAS PERFORMED ON THE DEVICE NUMBER WHICH DID NOT IDENTIFY A TREND ON THE COMPLAINT EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, THE 5.5 X 70 MM HEADLESS COMPRESSION SCREW DID NOT ADVANCE AND BECAME STUCK WHEN THE SURGEON TRIED TO REMOVED THE SCREW, THE HEAD POP OFF WITH THE SCREW. THE IMPLANT WAS REMAINED IN THE PATIENT AND THE SURGEON USED AN ADDITIONAL SCREW FIXATION. THERE WAS AN UNKNOWN SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - SCREWDRIVER: (PART#UNKNOWN; LOT# UNKNOWN; QUALITY:1) UNK - GUIDE/COMPRESSION/K-WIRES: (PART#UNKNOWN; LOT# UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090900 5.5MM TI CANN COMPRESSION HEADLESS SCREW LT 70MM HEADLESS SCREW HWC TYBER MEDICAL 04.334.670

    Patients

    Seq Age Sex Outcome Treatment
    1 Other