BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: 2.4 MM LCP DISTAL RADIUS VOLAR T-PLATE

    MDR report key: 12481446 · Received September 16, 2021

    Report

    Report Number
    8030965-2021-07790
    Event Type
    Injury
    Date Received
    September 16, 2021
    Report Date
    September 3, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN T-PLATE CONSTRUCT/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 JOURNAL ARTICLE: SJØLANDER, H.J. ET AL. (2021), X-RAY FOLLOW-UP AFTER OPEN REDUCTION INTERNAL FIXATION OF DISTAL FOREARM FRACTURE, JOURNAL OF WRIST SURGERY, VOL. 10, PAGES 150-153 (DENMARK). THE PURPOSE OF THIS STUDY WAS TO EVALUATE HOW OFTEN RADIOGRAPHS TAKEN AT A 2-WEEK OUTPATIENT VISIT RESULT IN A CHANGE IN THE STANDARD POSTOPERATIVE REGIMEN AND TREATMENT OF THE PATIENT. FURTHERMORE, WE WANTED TO EVALUATE WHETHER WE SHOULD CONTINUE WITH THIS ROUTINE FOLLOW-UP AT THE DEPARTMENTS STUDIED. OF THE PATIENTS INCLUDED IN THE STUDY, 311 PATIENTS (68 MALES AND 234 FEMALES WITH AN AVERAGE AGE OF 60 YEARS) WERE TREATED AT ZEALAND UNIVERSITY HOSPITAL (ZUH) BETWEEN JANUARY 1, 2009, AND MARCH 29, 2011. THERE WERE 302 PATIENTS (64 MALES AND 247 FEMALES WITH AN AVERAGE AGE OF 47 YEARS) TREATED AT THE UNIVERSITY HOSPITAL OF ODENSE (OUH) BETWEEN SEPTEMBER 1, 2017, AND DECEMBER 31, 2018. THE IMPLANTS USED WERE SYNTHES VARIABLE ANGLE LCP TWO-COLUMN PLATE AND SYNTHES T-PLATE. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 8 PATIENTS HAD A LOSS OF FRACTURE REDUCTION. THIS LED TO A FURTHER OPERATION OF 1.0% OF THE COHORT (PLATE REMOVAL OR RE-OSTEOSYNTHESIS). 19 PATIENTS HAD A CHANGE OF TREATMENT. 6 PATIENTS HAD REOPERATIONS. 10 PATIENTS HAD ADDITIONAL FOLLOW UP IN THE OUTPATIENT CLINIC. 3 PATIENTS HAD EXTENDED IMMOBILIZATION. THIS REPORT IS FOR AN UNKNOWN SYNTHES T-PLATE. THIS REPORT CAPTURES REPORTED EVENT OF LOSS OF FRACTURE REDUCTION. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1379020 UNK - CONSTRUCTS: 2.4 MM LCP DISTAL RADIUS VOLAR T-PLATE PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention