BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: EXPERT TIBIAL NAIL

    MDR report key: 9861457 · Received March 20, 2020

    Report

    Report Number
    8030965-2020-02153
    Event Type
    Injury
    Date Received
    March 20, 2020
    Report Date
    March 10, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE PATIENTS ALL INFORMATION IS PROVIDED IN THE ARTICLE. IMPLANT DATE IS BETWEEN 2009 AND 2012. THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: EXPERT TIBIAL NAIL/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI 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. (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: LADURNER A., ACKLIN Y., MUELLER T., SOMMER C., (2019) DECREASE SURGERY TIME BY USING AN ALTERNATIVE LATERAL PARAPATELLAR APPROACH FOR TIBIA SHAFT FRACTURE NAILING , ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY, VOLUME 139, PAGES 943¿949 (SWITZERLAND). THIS RETROSPECTIVE STUDY AIMS TO ASSESS WHETHER THE MEDIAL PARAPATELLAR, TRANSPATELLAR AND LATERAL PARAPATELLAR APPROACHES DIFFER IN THOSE ASPECTS OF SURGICAL MANAGEMENT. BETWEEN 2009 AND 2012, ALL PATIENTS TREATED BY INTRAMEDULLARY TIBIAL NAILING THROUGH EITHER A TRANSPATELLAR, A MEDIAL PARAPATELLAR OR A LATERAL PARAPATELLAR APPROACH FOR TIBIAL SHAFT FRACTURES AO TYPE 42 A¿C WERE REVIEWED. A TOTAL OF 73 (40 MALES AND 33 FEMALES) PATIENTS WITH OVERALL MEAN AGE OF 44 YEARS MET THE INCLUSION CRITERIA AND WERE INCLUDED IN THE STUDY. ALL FRACTURES WERE TREATED USING THE EXPERT TIBIAL NAIL (SYNTHES®, OBERDORF, SWITZERLAND). THE PATIENTS WERE FOLLOWED UP AT A MINIMUM OF 1 YEAR. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: (OVERALL COMPLICATION OCCURRED IN 6 OF 73 PATIENTS). ONE PATIENT SUFFERED WOUND-HEALING PROBLEMS WITHOUT OPERATIVE REVISION. FOUR PATIENTS UNDERWENT REVISION SURGERY BECAUSE OF MALALIGNMENT OF THE FRACTURE, ONE PATIENT SUFFERED FROM SUPERFICIAL AND ONE FROM DEEP WOUND INFECTION NEEDING REVISION. ONE DEEP INFECTION WAS SEEN WITH THE TRANSPATELLAR APPROACH, AND A SUPERFICIAL INFECTION OCCURRED IN THE LATERAL APPROACH GROUP. THIS REPORT IS FOR AN UNKNOWN SYNTHES EXPERT TIBIAL NAIL. THIS REPORT IS FOR ONE UNKNOWN CONSTRUCTS: EXPERT TIBIAL NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324684 UNK - CONSTRUCTS: EXPERT TIBIAL NAIL NAIL,FIXATION,BONE JDS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention