BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 18451909 · Received January 5, 2024

    Report

    Report Number
    3025141-2024-00009
    Event Type
    Injury
    Date Received
    January 5, 2024
    Report Date
    January 4, 2024
    Manufacturer
    ACUMED, LLC
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS DEVICE MODEL NUMBER AND BATCH/LOT NUMBER ARE UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    REPORT 5 OF 7. IN THE ARTICLE " A STUDY COMPARING THE OUTCOMES OF TRANSVERSE ULNAR SHORTENING OSTEOTOMY FIXED WITH A DCP TO OBLIQUE OSTEOTOMY FIXED WITH A PROCEDURE SPECIFIC PLATE" BY SINGHAL, R., ET AL, THE AIM OF THE AUTHORS' STUDY WAS TO COMPARE THE UNION RATE AND COMPLICATIONS OF A TRANSVERSE OSTEOTOMY (TO) FIXED WITH A DYNAMIC COMPRESSION PLATE TO AN OBLIQUE OSTEOTOMY (OO) FIXED WITH AN ACUMED PROCEDURE-SPECIFIC PLATE AND INSTRUMENTATION SYSTEM. A RETROSPECTIVE COHORT STUDY WAS CONDUCTED TO COMPARE THE RESULTS OF TRANSVERSE OSTEOTOMY (TO) FIXED WITH A SMALL FRAGMENT DYNAMIC COMPRESSION PLATE (DIFFERENT MANUFACTURER), TO OBLIQUE OSTEOTOMY (OO) FIXED WITH A PROCEDURE SPECIFIC PLATE AND INSTRUMENTATION SYSTEM (MANUFACTURED BY ACUMED LLC, OREGON, USA). A TOTAL OF 39 PATIENTS UNDERWENT TO AND 62 PATIENTS UNDERWENT OO BETWEEN 2007 AND 2016. THE MAIN OUTCOMES COMPARED WERE RATE OF UNION, DURATION OF RADIOLOGICAL HEALING, IMPLANT REMOVAL RATE AND OTHER COMPLICATIONS. THE FOLLOWING COMPLICATIONS WERE REPORTED: 2 PATIENTS HAD FAILURE OF FIXATION SHORTLY AFTER INDEX PROCEDURE REQUIRING REVISION SURGERY WITH LOCKING COMPRESSION PLATE. ONE OF THESE INSTANCES WAS ATTRIBUTED TO THE LACK OF SURGEON EXPERIENCE. FOR THE OTHER INSTANCE, THE PATIENT HAD RETURNED TO MANUAL LABOR ACTIVITIES SOON AFTER THEIR OSTEOTOMY. ONE PATIENT PATIENTS DEVELOPED NON-UNION: A 43-YEAR-OLD NON-SMOKER FEMALE IN WHOM THE OSTEOTOMY DID NOT HEAL FOR 6 MONTHS. THIS WAS TREATED WITH REVISION PROCEDURE INVOLVING REMOVAL OF THE LAG SCREW AND APPLICATION OF ILIAC CREST AUTOGRAFT TO ACHIEVE BONY CONTACT. 2 PATIENTS REQUIRED REMOVAL OF METALWORK FOR SYMPTOMS RELATED TO DISCOMFORT CAUSED BY PROMINENT IMPLANT. TWO PATIENTS DEVELOPED ALTERED SENSATION IN THE ULNAR NERVE DISTRIBUTION. BOTH OF THESE PATIENTS WERE MANAGED CONSERVATIVELY. THIS REPORT IS RELATED TO REPORT NUMBERS 3025141-2024-00005, 3025141-2024-00006, 3025141-2024-00007, 3025141-2024-00008, 3025141-2024-00010, 3025141-2024-00011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491644 PLATE, FIXATION, BONE HRS ACUMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other