BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2852079 · Received November 30, 2012

    Report

    Report Number
    2520274-2012-03469
    Event Type
    Injury
    Date Received
    November 30, 2012
    Report Date
    November 2, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. 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.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH LCP POSTERIOR DISTAL T-PLATE AND SCREW CONSTRUCT FOR PILON FRACTURE ON (B)(6) 2012. ROUTINE FOLLOW-UP X-RAY TAKEN ON AN UNKNOWN DATE REVEALED A NON-UNION. PATIENT UNDERWENT A TWO-STAGE REVISION. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2012 FOR THE FIRST STAGE REVISION SURGERY. THE SURGEON REMOVED ALL HARDWARE AND THE PATIENT WAS REVISED TO EXTERNAL FIXATION. PATIENT WAS THEN RETURNED TO THE OR ON (B)(6) 2012 FOR THE SECOND STAGE REVISION SURGERY. THE PATIENT WAS IMPLANTED WITH LOW BEND MEDIAL DISTAL TIBIA PLATE CONSTRUCT. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT.

    Description of Event or Problem · 1

    INITIAL REPORT: PATIENT WAS IMPLANTED WITH LCP POSTERIOR DISTAL T-PLATE AND SCREW CONSTRUCT FOR PILON FRACTURE ON (B)(6) 2012. ROUTINE FOLLOW-UP X-RAY TAKEN ON AN UNKNOWN DATE REVEALED A NON-UNION. PATIENT UNDERWENT A TWO-STAGE REVISION. PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 FOR THE FIRST STAGE REVISION SURGERY. THE SURGEON REMOVED ALL HARDWARE AND THE PATIENT WAS REVISED TO EXTERNAL FIXATION. PATIENT WAS THEN RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 FOR THE SECOND STAGE REVISION SURGERY. THE PATIENT WAS IMPLANTED WITH LOW BEND MEDIAL DISTAL TIBIA PLATE CONSTRUCT. UPDATED REPORT: A REPORT WAS RECEIVED REGARDING A PATIENT WHO IMPLANTED ON (B)(6) 2012 TO TREAT A COMMINUTED (WITH INTRAARTICULAR EXTENSION) FRACTURE OF LEFT DISTAL TIBIA AND FIBULA. IT WAS REPORTED THAT POST-OPERATIVELY, THE PATIENT USED A WALKER AND SUBSEQUENTLY THE NOTICED BOWING OF THE EXTREMITY. X-RAYS TAKEN ON (B)(6) 2012 REVEALED A LEFT ANKLE VARUS DRIFT, NEITHER BONE HEALED, AND AT LEAST ONE SCREW WAS BROKEN. THE PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 FOR REMOVAL OF ALL HARDWARE. DURING REMOVAL, IT WAS NOTICED THAT FOUR OF THE DISTAL SCREW HEADS HAD BROKEN OFF. THE SCREW HEADS AND PLATE WERE REMOVED. THE SURGEON ALSO REMOVED THE SCREW SHAFTS WITHOUT DIFFICULTY. ON (B)(6) 2012, THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR THE SECOND STAGE REVISION SURGERY. THE PATIENT WAS IMPLANTED WITH LOW BEND MEDIAL DISTAL TIBIA PLATE CONSTRUCT. THIS IS 2 OF 5 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention PLATE