BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PLATE/SCREWS

    MDR report key: 10809689 · Received November 9, 2020

    Report

    Report Number
    8030965-2020-08757
    Event Type
    Injury
    Date Received
    November 9, 2020
    Report Date
    October 13, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNK - CONSTRUCTS: PLATE/SCREWS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IMPLANTATION DATE 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 AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. (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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: PESCHIERA V., ET AL (2018) PREDICTING THE FAILURE IN DISTAL FEMUR FRACTURES , INJURY, INT. J. CARE INJURED VOLUME 49 S3, PAGES S2¿S7 ((B)(6)). THIS STUDY AIMS TO IDENTIFY FACTORS THAT CAN PREDICT NONUNION AND GIVE TECHNICAL PRINCIPLES FOR CORRECTION. FROM OCTOBER 2007 TO DECEMBER 2017, 86 DISTAL FEMORAL FRACTURES (PRE IMPLANT AND PATHOLOGICAL FRACTURE WERE EXCLUDED BY THE INITIAL 116 CASES), WITH 20 NONUNION CASES (13 MALES, 7 FEMALES) WERE INCLUDED IN THE STUDY. OF THE 20 NONUNION CASES, 12 HAD THEIR FIRST TREATMENT IN OTHER INSTITUTIONS, BUT ALL MEDICAL AND RADIOLOGICAL REPORTS AND IMAGES; 8 CASES ORIGINATE FROM OUR SERIES. AVERAGE AGE WAS 43 YEARS (RANGE 20¿76).IN THE FIRST REPAIRING SURGERY THE FOLLOWING HARDWARE WERE EMPLOYED: 15 LISS OR LCPDF (SYNTHES CO.); 2 NCB PLATES (ZIMMER CO.); 1 DCS PLATE E 2 HYBRID EXTERNAL FIXATORS. IN THE REVISION SURGERY A CORTICOCANCELLOUS GRAFT HARVESTED FROM THE ILIAC CREST (ONE OR BOTH SIDES) OR WITH THE REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM (DEPUY SYNTHES). MINIMUM FOLLOW UP WAS THREE MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: A CASE OF A (B)(6)-YEAR-OLD MALE (CASE NO.2) WHO UNDERWENT INITIAL SURGERY WITH DCS HAD ATROPHIC NONUNION. A CASE OF A (B)(6)-YEAR-OLD MALE (CASE NO.3) WHO UNDERWENT INITIAL SURGERY WITH LCP DF PLATE HAD OLIGOTROPHIC NONUNION. A CASE OF A (B)(6)-YEAR-OLD MALE (CASE NO. 4) WHO UNDERWENT INITIAL SURGERY WITH LCP DF PLATE HAD VARUS MALALIGNMENT AND ATROPHIC NONUNION. A CASE OF A (B)(6)-YEAR-OLD MALE (CASE NO.5) WHO UNDERWENT INITIAL SURGERY WITH LCP DF PLATE HAD OLIGOTROPHIC NONUNION. A CASE OF A (B)(6)-YEAR-OLD FEMALE (CASE NO. 6) WHO UNDERWENT INITIAL SURGERY WITH LCP DF PLATE HAD VARUS MALALIGNMENT AND OLIGOTROPHIC NONUNION. A CASE OF A (B)(6)-YEAR-OLD MALE ( CASE NO. 7) WHO UNDERWENT INITIAL SURGERY WITH LCP DF PLATE HAD VARUS MALALIGNMENT AND OLIGOTROPHIC NONUNION. A CASE OF A (B)(6)-YEAR-OLD MALE (CASE NO. 8) WHO UNDERWENT INITIAL SURGERY WITH LCP DF PLATE HAD OLIGOTROPHIC NONUNION. A CASE OF A (B)(6)-YEAR-OLD FEMALE (CASE NO. 10) WHO UNDERWENT INITIAL SURGERY WITH LCP DF PLATE HAD VARUS MALALIGNMENT AND ATROPHIC NONUNION. A CASE OF A (B)(6)-YEAR-OLD MALE (CASE NO. 12) WHO UNDERWENT INITIAL SURGERY WITH LCP DF PLATE HAD VARUS MALALIGNMENT AND ATROPHIC NONUNION. A CASE OF A (B)(6)-YEAR-OLD FEMALE (CASE NO. 13)WHO UNDERWENT INITIAL SURGERY WITH LCP DF PLATE HAD ATROPHIC NONUNION. A CASE OF A (B)(6)-YEAR-OLD FEMALE (CASE NO. 14)WHO UNDERWENT INITIAL SURGERY WITH LCP DF PLATE HAD OLIGOTROPHIC NONUNION. A CASE OF A (B)(6)-YEAR-OLD MALE (CASE NO. 15) WHO UNDERWENT INITIAL SURGERY WITH LCP DF PLATE HAD VARUS MALALIGNMENT AND OLIGOTROPHIC NONUNION. A CASE OF A (B)(6)-YEAR-OLD MALE (CASE NO. 16)WHO UNDERWENT INITIAL SURGERY WITH LCP DF PLATE HAD ATROPHIC NONUNION. A CASE OF A (B)(6)-YEAR-OLD FEMALE (CASE NO. 17) WHO UNDERWENT INITIAL SURGERY WITH LCP DF PLATE HAD VARUS MALALIGNMENT AND OLIGOTROPHIC NONUNION. A CASE OF A (B)(6)-YEAR-OLD MALE (CASE NO. 19) WHO UNDERWENT INITIAL SURGERY WITH LCP DF PLATE HAD VARUS MALALIGNMENT AND ATROPHIC NONUNION. A CASE OF A (B)(6)-YEAR-OLD FEMALE (CASE NO. 20 ) WHO UNDERWENT INITIAL SURGERY WITH LCP DF PLATE HAD ATROPHIC NONUNION. IN ALL CASES OF NONUNION EXCEPT ONE WE FOUND AN UNBALANCED FIXATION ACCORDING TO THE ABOVE CRITERIA. AN AXIAL DEFECT, IN MOST CASES IN VARUS, DUE TO LATERALIZATION OF THE DIAPHYSEAL FRAGMENT, WAS OBSERVED IN MORE THAN HALF CASES. ALL CASES EXCEPT ONE PRESENT A MEDIAL CORTICAL BONE DEFECT OF GREATER OR LESSER EXTENT. THIS CASE WAS A FAILURE OF A LISS. THE AXIS WAS RESTORED, AND NO MEDIAL CORTICAL DEFECT WAS DETECTED. THE PATIENT WAS SEVERELY OBESE AND OSTEOPOROTIC. WE REVISED IT WITH A MEGA PROSTHESIS. ALL NONUNION HEALED . FOUR OF 20 CASES NEEDED SECONDARY REVISION SURGERY TO ACHIEVE UNION. THIS REPORT IS FOR AN UNKNOWN SYNTHES LISS OR LCPDF, DCS PLATE, LCP 4.5 PLATE, AND LCP DFVA. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS FOR (1) UNK - CONSTRUCTS: PLATE/SCREWS. THIS IS REPORT 6 OF 10 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278519 UNK - CONSTRUCTS: PLATE/SCREWS SCREW,FIXATION,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention