BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORILLA PLATING SYSTEM

    MDR report key: 11600623 · Received April 1, 2021

    Report

    Report Number
    3008650117-2021-00077
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    September 1, 2020
    Report Date
    March 31, 2021
    Manufacturer
    PARAGON 28, INC.
    Product Code
    HWC
    PMA / PMN Number
    K190365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL OBSERVATION OF THE RETURNED PART WAS COMPLETED AND THE SCREW SHAFT IS VISIBLY SHORTER THAN IT SHOULD BE WHEN COMPARED TO PRINT AND DOES NOT CONTAIN THE SHAFT END/TIP. THE DEVICE HISTORY RECORD FOR LOT NUMBER PA5671/106 WAS REVIEWED AND SHOWS ALL INSPECTED PARTS WERE RECEIVED AND ACCEPTED. NO NCR IDENTIFIED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRIPLE ARTHRODESIS SURGICAL PROCEDURE ON (B)(6) 2020, A PARAGON 28 3.5 X 26MM TUFFNEK® LOCKING PLATE SCREW WAS REPORTED BROKEN. IT WAS REPORTED THAT AS THE SURGEON WAS INSERTING THE LOCKING SCREW, THE SCREW BROKE. PARTS OF THE SCREW WAS LEFT INSIDE PATIENT BECAUSE THE DOCTOR COULD NOT FISH IT OUT. THE SCREW SHAFT WAS RETURNED TO PARAGON 28. IT WAS SAID THAT THE DOCTOR EXPECTS FULL RECOVERY WITH PATIENT. MALE PATIENT, AGE RANGE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503826 GORILLA PLATING SYSTEM 3.5 X 26 MM LOCKING PLATE SCREW HWC PARAGON 28, INC. P50-053-3526 PA5671/106

    Patients

    Seq Age Sex Outcome Treatment
    1