BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 7452792 · Received April 23, 2018

    Report

    Report Number
    8030965-2018-53306
    Event Type
    Malfunction
    Date Received
    April 23, 2018
    Report Date
    April 3, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. INCORRECTLY REPORTED AS SERIOUS INJURY IN PREVIOUS MEDWATCH. CORRECT TYPE OF REPORTABLE EVENT IS MALFUNCTION. 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.

    Additional Manufacturer Narrative · 1

    DEVICE USED IN A VETERINARY CASE - NO PATIENT INFORMATION WILL BE REPORTED. DATE OF EVENT: UNKNOWN. THIS REPORT IS FOR AN UNKNOWN PLATE/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IMPLANTED, EXPLANTED 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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) LITERATURE ARTICLE.PDF].

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING LITERATURE ARTICLE: PRAT, S. ET. AL. (2018). CLINICAL TRANSLATION OF A MESENCHYMAL STROMAL CELL-BASED THERAPY DEVELOPED IN A LARGE ANIMAL MODEL AND TWO CASE STUDIES OF THE TREATMENT OF ATROPHIC PSEUDOARTHROSIS. JOURNAL OF TISSUE ENGINEERING AND REGENERATIVE MEDICINE, 12(1). THIS STUDY HIGHLIGHTS THE TREATMENT OF ATROPHIC PSEUDOARTHROSIS WITH MESENCHYMAL STROMAL CELL-BASED THERAPY BY ARTIFICIALLY INDUCING AND TREATING THE PSEUDOARTHROSIS IN AN ANIMAL MODEL COMPRISED OF SIXTEEN (16) EWES (FEMALE SHEEP), AND FURTHER DEMONSTRATING THE EFFICACY OF THIS TREATMENT IN TWO (2) HUMAN PATIENTS WHOSE CASES HAVE BEEN PRESENTED IN THIS ARTICLE AS CASE STUDIES. THE MESENCHYMAL STROMAL CELL-BASED THERAPY IS CALLED TISSUE-ENGINEERING PRODUCT (TEP) IN THIS STUDY. THE EWES SELECTED FOR THE STUDY WERE ALL RIPOLLESA-LACONA BREED AND WERE TWENTY (20) MONTHS OLD. A CRITICAL SIZE SEGMENTAL TIBIAL DEFECT WAS INDUCED SURGICALLY INTO ALL THE EWES AND THEY WERE RANDOMLY DISTRIBUTED INTO THREE (3) EXPERIMENTALLY GROUPS, NAMELY, GOLD STANDARD, SCAFFOLD WITHOUT CELLS AND CELL-LOADED SCAFFOLD BASED ON THE TREATMENTS APPLIED TO THE INDUCED DEFECT IN THEIR TIBIA. FURTHER, AFTER APPLYING THE TREATMENTS, TIBIA WERE STABILIZED BY CONTRALATERAL FIXATION USING TWO LIMITED CONTACT DYNAMIC COMPRESSION PLATES (LC-DCP) PER TIBIA. AN EIGHT-HOLE LC-DCP (SYNTHES, DAVOS, SWITZERLAND) WITH A TOTAL OF SIX (6) CORTICAL SCREWS (SYNTHES) OF SIZES BETWEEN 18 AND 22 MM IN LENGTH WERE USED ON THE MEDIAL SIDE. A SIX-HOLE LC-DCP (SYNTHES) WITH A TOTAL OF FOUR (4) CORTICAL SCREWS, 18 AND 22 MM LONG WERE USED ON THE LATERAL SIDE. PLATE FIXATION WAS REPORTED TO HAVE BEEN STABLE IN ALL ANIMALS DURING THE COURSE OF THE THREE (3) MONTH FOLLOW-UP PERIOD. COMPLICATIONS IN ANIMAL MODEL: THREE (3) OF THEM WHO WERE NUMBERED 4, 6 AND 7 DEVELOPED AN INFECTION AT THE DEFECT SITE, AND WERE HENCE EUTHANIZED. SHEEP NUMBER 14 WAS LATER CONFIRMED TO HAVE AN INFECTION AT THE TIME OF HARVESTING ITS TIBIA FOR FURTHER HISTOLOGICAL ANALYSES. TO SUMMARIZE, FOUR (4) OUT OF THE SIXTEEN ANIMALS DEVELOPED AN INFECTION AT THE SITE WHERE THE DEFECT WAS INDUCED. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294020 PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1