BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PLATE/SCREWS

    MDR report key: 10697025 · Received October 19, 2020

    Report

    Report Number
    8030965-2020-08030
    Event Type
    Injury
    Date Received
    October 19, 2020
    Report Date
    September 23, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN PLATE AND SCREW CONSTRUCT/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DATE OF IMPLANTATION IS AN UNKNOWN DATE BETWEEN JUNE 2016 AND JUNE 2018. 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: AN, L. ET AL. (2020), CLINICAL COMPARISON OF SINGLE-INCISION AND DUAL-INCISION APPROACHES FOR THE TREATMENT OF DISTAL TIBIAL AND FIBULAR FRACTURES: A RANDOMIZED CONTROLLED TRIAL, JOURNAL OF ORTHOPAEDIC SURGERY, VOL. 28(2), PAGES 1¿8 ((B)(6)). HTTPS://DOI.ORG/10.1177/2309499020930305. THE PURPOSE OF THIS STUDY WAS TO CLINICALLY COMPARE THE SINGLE-INCISION AND DUAL-INCISION APPROACHES FOR THE TREATMENT OF DISTAL TIBIAL AND FIBULAR FRACTURES. BETWEEN JUNE 2016 AND JUNE 2018, 93 PATIENTS PRESENTING WITH DISTAL TIBIAL AND FIBULAR FRACTURES UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION USING EITHER ONE-THIRD TUBULAR PLATE OR DISTAL FIBULAR ANATOMICAL LOCKING PLATE (AO/SYNTHES, NEW JERSEY, USA). 45 PATIENTS WERE TREATED USING THE SINGLE-INCISION APPROACH (GROUP 1) AND 48 PATIENTS WERE TREATED USING THE DUAL-INCISION APPROACH (GROUP 2). THE MEAN FOLLOW-UP WAS 15 MONTHS (RANGE 12¿19 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED: GROUP 1: 2 PATIENTS HAD SKIN SLOUGH, 2 PATIENTS HAD DELAYED UNION, 4 PATIENTS HAD NERVE INJURY, 1 PATIENT HAD AN INFECTION. GROUP 2: 5 PATIENTS HAD SKIN SLOUGH, 2 PATIENTS HAD SUPERFICIAL INFECTION, 2 PATIENTS HAD NONUNION WHICH REQUIRED SURGICAL REVISIONS AND EVENTUALLY HEALED AFTER INTERVENTION, 5 PATIENTS HAD DELAYED UNION, 1 PATIENT HAD A NERVE INJURY. 3 PATIENTS WHO HAD SKIN SLOUGH WHICH REQUIRED SURGICAL REVISIONS AND EVENTUALLY HEALED AFTER INTERVENTION. THIS REPORT IS FOR AN UNKNOWN SYNTHES ONE-THIRD TUBULAR PLATE AND DISTAL FIBULAR ANATOMICAL LOCKING PLATE ((B)(6), USA). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163377 UNK - CONSTRUCTS: PLATE/SCREWS PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention