BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 24466106 · Received February 27, 2026

    Report

    Report Number
    3025141-2026-00182
    Event Type
    Injury
    Date Received
    February 27, 2026
    Report Date
    February 26, 2026
    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

    THE DEVICE WAS NOT RECEIVED FOR EVALUATION. MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS DEVICE INFORMATION IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    A LITERATURE REVIEW IDENTIFIED THE ARTICLE, TEUNISSEN JS, VAN DER OEST MJW, SELLES RW, ET AL. LONG-TERM OUTCOMES AFTER ULNA SHORTENING OSTEOTOMY: A MEAN FOLLOW-UP OF SIX YEARS. BONE & JOINT OPEN. 2022 MAY;3(5):375-382. DOI: 10.1302/2633-1462.35.BJO-2022-0031.R1. PMID: 35514114; PMCID: PMC9134835. IN THIS OBSERVATIONAL PROSPECTIVE STUDY, PATIENTS WHO UNDERWENT AN ULNA SHORTENING OSTEOTOMY WERE CONTACTED FOR A LATE FOLLOW-UP TO ASSESS FOR PATIENT REPORTED PAIN AND FUNCTIONAL OUTCOMES. IN ADDITION, PATIENTS WERE QUESTIONED ON THEIR TREATMENT SATISFACTION, COMPLICATIONS, AND ADDITIONAL TREATMENT FOR ANY PERSISTENT/RECURRENT ULNAR-SIDED PAIN. ALL 66 PATIENTS WERE TREATED BETWEEN JULY 2011 TO FEBRUARY 2017 AND HAD A PRIOR PATIENT RATED WRIST/HAND EVALUATION (PRWHE) SCORE BEFORE SURGERY. THE MEAN AGE OF THE PATIENTS WAS 46 ± 13 YEARS. THERE WERE 21 MALE AND 45 FEMALE PATIENTS IN THIS COHORT. FOR THE ULNA SHORTENING OSTEOTOMY, PLATES FROM ACUMED (26 PATIENTS), BIOMET (1 PATIENT), SYNTHES ULNAR PLATE (3 PATIENTS), OR A SYNTHES LCP/LC-DCP PLATE (33 PATIENTS). PATIENTS COMPLICATIONS REPORTED INCLUDED THE NEED FOR SUBSEQUENT THERAPY FOR WRIST PAIN (13 PATIENTS), HARDWARE REMOVAL (42 PATIENTS) AT A MEDIAN OF 11.2 MONTHS, AND NONUNION (8 PATIENTS) AT A MEDIAN OF 5.4 MONTHS. PRWHE SCORES IMPROVED FROM 63 (RANGE 58-68) PRIOR TO SURGERY TO 19 (RANGE 14 TO 24) AT 6 YEARS POST-SURGERY. OVERALL PATIENT SATISFACTION WAS REPORTED IN 58 PATIENTS, WHO INDICATED THEY WOULD UNDERGO THE SAME TREATMENT AGAIN UNDER SIMILAR CIRCUMSTANCES. THESE RESULTS LEAD THE AUTHORS TO CONCLUDE THAT THE USE OF ULNA SHORTENING OSTEOTOMIES FOR ULNA IMPACTION SYNDROME YIELDED SATISFIED PATIENT OUTCOMES, BUT THERE ARE HIGH LEVELS OF NEEDING REOPERATION TO REMOVAL HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526994 PLATE, FIXATION, BONE HRS ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other