BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTOS MTP PLATE EXTRA SMALL LEFT

    MDR report key: 11928446 · Received June 3, 2021

    Report

    Report Number
    3008951116-2021-00005
    Event Type
    Injury
    Date Received
    June 3, 2021
    Date of Event
    May 6, 2021
    Report Date
    May 10, 2021
    Manufacturer
    ORTHO SOLUTIONS UK LTD
    Product Code
    HRS
    UDI-DI
    05055662918199
    PMA / PMN Number
    K141784
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INVESTIGATION UNDERTAKEN, THE FOLLOWING CONCLUSIONS WERE MADE: THE DEFINITIVE ROOT CAUSE FOR PLATE FRACTURE COULD NOT BE ASCERTAINED. HOWEVER, BASED ON REVIEW OF THE DHR, VISUAL INSPECTION OF THE RETURNED PLATE AND CLINICAL INFORMATION, THE CAUSE FOR PLATE FAILURE WAS LIKELY MULTI-FACTORIAL. A COMBINATION OF POSSIBLE CONTOURING OF THE PLATE RESULTING IN STRESS CONCENTRATIONS, IMPLANTATION PROCEDURE WITH POSSIBLE OVER COMPRESSION, AND PATIENT COMORBIDITY OF HIGH BMI WOULD HAVE ALL CONTRIBUTED TO THE FRACTURE OF THE PLATE. NO FURTHER INFORMATION REGARDING POST-OPERATIVE PROTOCOL AND COMPLIANCE TO THE PROTOCOL WAS PROVIDED. IT WAS REPORTED THAT THE PATIENT DID NOT ENCOUNTER ANY ACCIDENT WHICH MAY HAVE CAUSED THE PLATE TO FRACTURE AFTER IMPLANTATION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THE BATCH WAS PASSED WITH NO NON-CONFORMANCES RAISED, AND NO DEVIATIONS WERE NOTED IN THE CONSTITUENT MATERIAL. TREND ANALYSIS OF THE OS42260XSL PLATE SHOWS THAT THIS IS THE FIRST INSTANCE OF IMPLANT BREAKAGE REPORTED, AND THE FAILURE RATE IS DEEMED AS LOW. BASED ON THE PRODUCT FAILURE RATE AND THE RESULTS FROM THE INVESTIGATIONS CONDUCTED, THERE ARE CURRENTLY NO CORRECTIVE ACTIONS TO BE TAKEN. THIS COMPLAINT WILL HOWEVER BE MONITORED THROUGH ORTHO SOLUTION'S POST MARKET SURVEILLANCE PROCEDURES FOR RE-OCCURRENCE AND ANY EVIDENCE OF NEGATIVE TREND.

    Description of Event or Problem · 1

    SURGEON PERFORMED AN MTP FUSION ON A (B)(6)-YEAR-OLD FEMALE WITH HIGH BMI. THE SURGERY WAS IN (B)(6) 2020 SO POST-OP REVIEWS WERE ON PHONE DUE TO LOCKDOWN. THE SURGEON SAW THE PATIENT IN HER CLINIC WITH A NON-UNION & BROKEN PLATE IN (B)(6) 2021. ON THE (B)(6) 2021, THE PATIENT CAME BACK IN FOR SURGERY FOR REMOVAL OF PLATE. NO EXTRA IMPLANTS WERE USED. PATIENT HAS BEEN LEFT WITH A NON-UNION. ASIDE FROM THE AFOREMENTIONED, NO FURTHER PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827353 ULTOS MTP PLATE EXTRA SMALL LEFT ORTHOPAEDIC FIXATION PLATE, NON-BIOABSORBABLE, STERILE HRS ORTHO SOLUTIONS UK LTD OS42260XSL 2018000441 05055662918199

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other