BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE,FIXATION,BONE

    MDR report key: 7448518 · Received April 20, 2018

    Report

    Report Number
    8030965-2018-53277
    Event Type
    Injury
    Date Received
    April 20, 2018
    Report Date
    April 3, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR ONE (1) UNKNOWN TIBIA PLATE. PART#, LOT# AND UDI # IS NOT AVAILABLE. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER PHONE NUMBER WAS NOT PROVIDED. THIS REPORT IS FOR ONE (1) UNKNOWN TIBIA PLATE. PMA/510(K) NUMBER IS NOT AVAILABLE. PATIENT CODE (B)(4) USED TO CAPTURE ADDITIONAL MEDICAL/SURGICAL INTERVENTION REQUIRED. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. ADDITIONALLY, DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. 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 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,(B)(4)) 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. HUMAN CASE STUDY 1: ONE (1) (B)(6) MALE PATIENT FELL AND SUFFERED A METAPHYSO-DIAPHYSEAL HUMERUS FRACTURE ON AN UNKNOWN DATE. THIS PATIENT WAS TREATED ONE (1) RETROGRADE INTRAMEDULLARY NAIL (UHN NAIL, SYNTHES) IN (B)(6) 2014. IN (B)(6) 2015, AFTER REALIZING A NONUNION WAS CAUSED ON AN UNKNOWN DATE, THE PATIENT WAS TREATED BY FILLING THE DEFECT UP WITH TEP AND BEING REVISED TO AN UNKNOWN LCP EXTRA-ARTICULAR DISTAL HUMERUS PLATE. THE PATIENT UNDERWENT THE REVISION SURGERY IN THE CONTEXT OF A RANDOMIZED CLINICAL TRIAL (NO.(B)(4)) THAT WAS CONDUCTED TO EVALUATE SAFETY AND EFFICACY USING A TEP LOADED WITH EXPANDED AUTOLOGOUS BONE MARROW (BM) DERIVED MESENCHYMAL STROMAL (MSC) CELLS. COMPLICATIONS IN HUMAN CASE STUDY 1: NONUNION AT NINE (9) MONTHS AFTER INITIAL IMPLANT OF ONE (1) RETROGRADE INTRAMEDULLARY NAIL (UHN NAIL, SYNTHES) IN (B)(6) 2014 LEADING TO REVISION SURGERY. HUMAN CASE STUDY 2: ONE (1) (B)(6) FEMALE PATIENT WAS REPORTED TO HAVE UNDERWENT AN EXPERIMENTAL TREATMENT IN (B)(6) 2014 AFTER A COMPASSIONATE USE OF CELL-BASED THERAPIES WAS APPROVED AFTER BEING DIAGNOSED WITH RECALCITRANT ATROPHIC PSEUDOARTHROSIS. THIS PATIENT WAS IDENTIFIED AS BEING A HEAVY SMOKER, ALLERGIC TO PENICILLIN, STREPTOMYCIN AND TETRACYCLINE. IN (B)(6) 2010, THIS PATIENT WAS IN A ROAD TRAFFIC ACCIDENT AND HAD SUFFERED SPLENIC LACERATION, OPEN BOOK PELVIC FRACTURE WITH SACRAL WING FRACTURE, CLOSED DIAPHYSEAL FRACTURE OF THE RIGHT FEMUR, OPEN GUSTILLO GRADE IIIA PROXIMAL DIAPHYSEAL LEFT TIBIA, FIBULA FRACTURE AND COMMINUTED FRACTURE OF THE LEFT PATELLA. THIS PATIENT WAS INITIALLY TREATED WITH AN UNKNOWN RETROGRADE INTRAMEDULLARY NAIL IMPLANTED IN THE RIGHT FEMUR AND ANTEGRADE NAIL IMPLANTED IN THE LEFT TIBIA. THIS PATIENT DEVELOPED DEVELOPED SKIN NECROSIS ON THE PROXIMAL AREA OF THE TIBIA TREATED WITH A SKIN GRAFT. ABOUT TWO (2) MONTHS AFTER THIS, THE PATIENT DEVELOPED A SECONDARY FRACTURE MOTION CAUSED BY A FAILURE OF THE PROXIMAL NAIL FIXATION AT THE ORIGINAL IMPLANT SITE. THE PATIENT UNDERWENT A REVISION AT THIS POINT TO ONE (1) PROXIMAL TIBIAL PLATE (LISS PT; SYNTHES). THE FOLLOWING SECTION DESCRIBES THE COMPLICATIONS THAT RESULTED DUE TO SYNTHES IMPLANTS IN THIS PATIENT. COMPLICATIONS IN HUMAN CASE STUDY 2: IT WAS NOTICED THAT THE FRACTURE DID NOT CONSOLIDATE AFTER THE IMPLANT OF THE PROXIMAL TIBIAL PLATE (LISS PT; SYNTHES) AND HENCE THE PATIENT UNDERWENT ANOTHER SURGERY TO DYNAMIZE THE NAIL, AND TO BE INJECTED WITH A BM ASPIRATE. FIVE MONTHS AFTER THE NAIL WAS DYNAMIZED, ATROPHIC PSEUDOARTHROSIS WAS OBSERVED ON THE TIBIA WHICH WAS TREATED WITH A TIBIAL RESECTION AND REPLACEMENT BY TRICORTICAL AUTOGRAFT FROM THE CONTRALATERAL ILIAC GRAFT, AND THE PATIENT WAS REVISED TO A MEDIAL PRECONTOURED PROXIMAL TIBIAL PLATE (SYNTHES) AND A TERIPARATIDE TREATMENT. A POST-OPERATIVE INFECTION (ENTEROBACTER CLOACAE AND PROTEUS MIRABILIS) WAS DIAGNOSED ON AN UNKNOWN DATE AFTER THE PATIENT WAS IMPLANTED WITH THE MEDIAL PRECONTOURED PROXIMAL TIBIAL PLATE (SYNTHES) AND WAS TREATED WITH SURGICAL DEBRIDEMENT AND ANTIBIOTIC TREATMENT WITH RIFAMPICIN AND CIPROFLOXACIN. SKIN NECROSIS WAS OBSERVED AND VACUUM-ASSISTED CLOSURE (VAC) THERAPY WAS APPLIED. PATIENT COULD MOVE WITH HELP OF CRUTCHES, BUT COMPLAINED OF PAIN AT THE FRACTURE SITE. THE PATIENT WAS THEN REVISED TO ONE (1) EXPERT TIBIAL NAIL (ETN; SYNTHES) WITH ANGULAR STABLE LOCKING SYSTEM SCREWS (ASLS; SYNTHES) FOR A PROXIMAL AND DISTAL FIXATION. POST-OPERATIVELY, THE PATIENT SUFFERED A SUPERFICIAL (B)(6) INFECTION (TREATED WITH VANCOMYCIN) WITH SKIN NECROSIS (REQUIRED VAC THERAPY AGAIN) AT THE SITE OF EXPERT TIBIAL NAIL (ETN; SYNTHES) WITH ANGULAR STABLE LOCKING SYSTEM SCREWS (ASLS; SYNTHES) IMPLANT. ELECTRO WAVE SHOCK THERAPY (EWST) WAS APPLIED TO THE TIBIA AND FEMUR WITHOUT ANY RADIOLOGICAL SUCCESS AND THE PATIENT REQUESTED AN AMPUTATION. AFTER CONFIRMING THE ABSENCE OF INFECTION AT THE PSEUDOARTHROSIS SITE BY CRP DETERMINATION AND SCINTIGRAPHY, A TEP TREATMENT WAS APPLIED AT THE DEFECT, THE EXISTING SYNTHES CONSTRUCT WAS REVISED TO A STRYKER TRIAX EXTERNAL FIXATION AND THE DEFECT WAS THEN FILLED WITH GENTAMYCIN CEMENT. 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. (B)(4) CAPTURES THE HUMAN CASES IN THE LITERATURE ARTICLE, AND (B)(4) CAPTURES THE ANIMAL CASES. THIS REPORT IS FOR ONE (1) UNKNOWN TIBIA PLATE. THIS IS REPORT 2 OF 8 FOR (B)(4). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289989 PLATE,FIXATION,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention