BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, NAIL

    MDR report key: 4753355 · Received May 6, 2015

    Report

    Report Number
    2520274-2015-13647
    Event Type
    Injury
    Date Received
    May 6, 2015
    Report Date
    April 17, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    KTT
    PMA / PMN Number
    PK000684
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR ONE UNKNOWN 3.7MM CANNULATED LOCKING SCREW. PARTIAL PART NUMBER WAS REPORTED AS 02.240.XXX. THIS PARTIAL NUMBER AND DESCRIPTION WAS ENOUGH TO ASSOCIATE THE PRODUCT FAMILY AS BELONGING TO SYNTHES 3.7MM CANNULATED LOCKING SCREW (LENGTH UNKNOWN), 510(K) K000684, PRODUCT DEVICE CODE-KTT, COMMON NAME- APPLIANCE, FIXATION, NAIL. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2015 DUE TO FIXATION FAILURE. THE PATIENT ALSO HAD COMPLAINTS OF PAIN AND INSTABILITY. IT WAS ALSO REPORTED THAT THREE DISTAL CORTEX SCREWS WERE PULLING OUT OF THE BONE. THE PATIENT WAS INITIALLY IMPLANTED WITH ONE 3-HOLE 3.5 MM LOCKING COMPRESSION PLATE (LCP) PROXIMAL HUMERUS PLATE, EIGHT 3.7 MM CANNULATED LOCKING SCREWS AND THREE 3.5 MM CORTEX SCREWS ON (B)(6) 2015 TO TREAT A THREE PART PROXIMAL LEFT HUMERAL FRACTURE. THE 12 IMPLANTS WERE REMOVED FROM THE PATIENT DURING THE (B)(6) 2015 REVISION SURGERY. THE IMPLANTS WERE REMOVED EASILY AND WITHOUT ADDITIONAL INTERVENTION OR UNANTICIPATED SURGICAL DELAY. THE PATIENT WAS SUCCESSFULLY REVISED WITH A 7-HOLE 3.5 MM LCP PROXIMAL HUMERUS PLATE AND ASSOCIATED HARDWARE. THE PATIENT¿S OUTCOME WAS REPORTED AS ¿GOOD.¿ THIS REPORT IS FOR ONE UNKNOWN 3.7MM CANNULATED LOCKING SCREW. THIS IS REPORT 6 OF 12 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296120 APPLIANCE, FIXATION, NAIL KTT SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention