BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 7396239 · Received April 4, 2018

    Report

    Report Number
    2939274-2018-51434
    Event Type
    Injury
    Date Received
    April 4, 2018
    Report Date
    March 8, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT IDENTIFIER, DATE OF BIRTH, AND WEIGHT NOT AVAILABLE FOR REPORTING. LITERATURE SOURCE : MARWAN, YOUSEF AND ET AL. (2017) "LOCKING SCREW MIGRATION TO THE PALM FOUR YEARS FOLLOWING SURGICAL IMPLANTATION OF DISTAL RADIUS LOCKING PLATE". THE JOURNAL OF HAND SURGERY-ASIAN PACIFIC VOLUME, 2017; 22 (3): 363-365 (CANADA). DEVICE NOT EXPECTED TO RETURN FOR INVESTIGATION. INITIAL REPORTER IS AUTHOR. 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

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING LITERATURE ARTICLE MARWAN, YOUSEF AND ET AL. (2017) "LOCKING SCREW MIGRATION TO THE PALM FOUR YEARS FOLLOWING SURGICAL IMPLANTATION OF DISTAL RADIUS LOCKING PLATE". THE JOURNAL OF HAND SURGERY-ASIAN PACIFIC VOLUME, 2017; 22 (3): 363-365 (CANADA). IN THIS ARTICLE, A CASE STUDY OF SCREW LOOSENING AND MIGRATION FOUR YEARS POST-OPERATIVELY FOLLOWING A VOLAR LOCKING PLATE FIXATION OF A DISTAL RADIUS FRACTURE WAS REVIEWED. A RIGHT HANDED (B)(6) -YEAR OLD FEMALE PATIENT SUSTAINED A RIGHT-SIDED DISTAL RADIUS FRACTURE AND WAS TREATED WITH OPEN REDUCTION AND INTERNAL FIXATION (ORIF) USING A VOLAR LOCKING PLATE CONSTRUCT. INITIALLY THE PATIENT ACHIEVED BONE HEALING AND RANGE OF MOTION WITHING SIX WEEKS FOLLOWING THE PROCEDURE. FOUR YEARS FOLLOWING THE SURGERY, THE PATIENT PRESENTED WITH RIGHT WRIST AND HAND PAIN WITH INCREASING SEVERITY AND REDUCED RANGE OF MOTION OF THE HAND AND FINGERS. IT WAS CONFIRMED THERE WAS NO INFECTION. X-RAYS WERE TAKEN ON AN UNKNOWN DATE AND SHOWED A MIGRATED DISTAL LOCKING SCREW FROM THE DISTAL RADIUS TO THE PALM, BETWEEN THE THIRD AND FOURTH METATARSAL BONES. THE MIGRATED SCREW WAS REMOVED SURGICALLY UNDER FLUOROSCOPIC GUIDANCE. THE PATIENT REPORTED A COMPLETE RELIEF OF PAIN AND REGAINED RANGE OF MOTION WITHIN TEN DAYS POST-OPERATIVELY. NO OTHER COMPLICATIONS DEVELOPED FROM THE REVISION SURGERY. COMPLICATIONS LISTED FOR THE CASE STUDY INCLUDE: SCREW MIGRATION, PAIN, LIMITED RANGE OF MOTION AND REVISION SURGERY. CONCOMITANT DEVICES: VOLAR LOCKING PLATE (PART# UNKNOWN, LOT# UNKNOWN, QTY 1); 2.4MM DISTAL LOCKING SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QTY 3); 2.7MM PROXIMAL CORTICAL SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QTY 3). THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR ONE UNKNOWN LOCKING SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239600 SCREW, FIXATION, BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention