BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 22391641 · Received July 2, 2025

    Report

    Report Number
    3025141-2025-00229
    Event Type
    Injury
    Date Received
    July 2, 2025
    Report Date
    July 2, 2025
    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 OF THE REPORTED EVENT IS UNKNOWN. BELOW ARE ALL RELATED REPORT NUMBERS REGARDING THIS LITERATURE REVIEW (5 TOTAL FOR THIS ARTICLE): NOTE, THIS MDR IS INCLUDED IN THE LIST BELOW. 3025141-2025-00230, 3025141-2025-00231, 3025141-2025-00232, 3025141-2025-00233.

    Description of Event or Problem · 0

    DURING A LITERATURE REVIEW, IN THE FOLLOWING ARTICLE CITED, "PARK I, PARK H, OH S, KANG S. RADIOLOGICAL PARAMETERS FOR PREDICTING THE RISK OF FLEXOR TENDON RUPTURE AFTER VOLAR PLATE FIXATION FOR DISTAL RADIUS FRACTURE CLINICS IN ORTHOPEDIC SURGERY. 2025 MAY;17(3):488-496. PMCID: PMC12104022. ". A RETROSPECTIVE REVIEW OF MEDICAL RECORDS OF PATIENTS WHO UNDERWENT VOLAR LOCKING PLATE (VLP) FIXATION FOR DISTAL RADIUS FRACTURES AT 2 HOSPITALS BETWEEN JANUARY 2010 AND DECEMBER 2020, OF WHICH FIFTEEN PATIENTS WERE TREATED FOR COMPLETE FLEXOR TENDON RUPTURE AFTER VLP FIXATION FOR DISTAL RADIUS FRACTURE. THE CONTROL POPULATION COMPRISED PATIENTS WITHOUT TENDON INJURY OR RUPTURE COMPLICATIONS FOR AT LEAST 3 YEARS AFTER VLP FIXATION WHO WERE AGE-, SEX-, AND FRACTURE TYPE-MATCHED (1 : 3) TO THOSE WITH FLEXOR TENDON RUPTURE USING PROPENSITY SCORE MATCHING (PSM). PSM WAS PERFORMED TO CONTROL POTENTIAL CONFOUNDING VARIABLES AND ENSURE COMPARABILITY BETWEEN THE FLEXOR TENDON RUPTURE GROUP AND CONTROL GROUP. IN THIS STUDY, VARIOUS TYPES OF VLPS WERE USED. IN THE CONTROL GROUP, ACU-LOC PLATES (18 CASES) AND SYNTHES PLATES (19 CASES) WERE THE MOST COMMONLY USED, WHILE IN THE FLEXOR TENDON RUPTURE GROUP, ACU-LOC PLATES (5 CASES) AND SYNTHES PLATES (6 CASES) WERE PREDOMINANT. FOR THE ACU-LOC PLATES, THREE (3) PATIENTS HAD FLEXOR POLLICIS LONGUS RUPTURES AND TWO (2) PATIENTS HAD INDEX FINGER FLEXOR DIGITORUM PROFUNDUS RUPTURES. HOWEVER, NO SIGNIFICANT ASSOCIATION WAS OBSERVED BETWEEN THE PLATE TYPE AND FLEXOR TENDON RUPTURE. PSM WAS PERFORMED TO BALANCE THE GROUPS FOR AGE, SEX, AND FRACTURE TYPE (AO CLASSIFICATION); HOWEVER, NO SIGNIFICANT DIFFERENCES IN AGE, SEX, OR FRACTURE TYPE WERE OBSERVED BETWEEN THE GROUPS (P > 0.05 FOR ALL VARIABLES). RADIOGRAPHIC FACTORS WERE RECORDED, INCLUDING MEASURES OF SAGITTAL (SOONG GRADE) AND FOR THE ADDITIONAL PARAMETERS: DISTANCE BETWEEN THE PLATE AND VOLAR CRITICAL LINE (PLATE-TO-CRITICAL LINE DISTANCE [PCLD]) AND THE DISTAL PLATE POSITION, RADIAL TILT, ULNAR VARIANCE, CORONAL CARPAL TRANSLATION, RADIUS-RADIAL STYLOID DISTANCE MEASURED FROM PA RADIOGRAPHS, VOLAR TILT, SAGITTAL CARPAL ALIGNMENT (SCA), AND RADIUS-VOLAR LIP DISTANCE (RVLD) MEASURED FROM LATERAL RADIOGRAPHS. STATISTICAL ANALYSIS CONFIRMED NO SIGNIFICANT DIFFERENCES IN AGE, SEX, OR FRACTURE TYPE BETWEEN THE GROUPS AFTER MATCHING. OUTCOMES ASSESSED WERE FLEXOR TENDON IRRITATION, RUPTURE, AND THE NEED FOR PLATE REMOVAL FOR ANY REASON. THE DATA WERE ASSESSED USING MULTIVARIABLE LOGISTIC REGRESSION MODELS TO ADJUST FOR PATIENT AND SURGICAL FACTORS. THE AUTHORS CONCLUDED THAT LIKELIHOOD OF HAVING A HIGHER SOONG GRADE WAS GREATER IN THE FLEXOR TENDON RUPTURE GROUP THAN IN THE CONTROL GROUP. IN THE COMPARISON BETWEEN GROUPS WITH GRADES 0 AND 1 AND THOSE WITH GRADES 0 AND 2 IN BINARY LOGISTIC REGRESSION, LARGE ODDS RATIOS WERE OBSERVED FOR THE GROUPS WITH GRADES 1 AND 2; HOWEVER, OWING TO THE SMALL NUMBER OF PATIENTS, THESE FINDINGS WERE NOT CONSIDERED STATISTICALLY SIGNIFICANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201593 PLATE, FIXATION, BONE HRS ACUMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other