BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS

    MDR report key: 11880809 · Received May 25, 2021

    Report

    Report Number
    8030965-2021-04272
    Event Type
    Injury
    Date Received
    May 25, 2021
    Report Date
    April 28, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN TOMOFIX PLATE/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K 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. 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: DRAENERT M.E., ET AL (2014)PRIMARY CANCELLOUS BONE FORMATION AROUND MICRO-CHAMBERED BEADS,REV ESP CIR ORTOP TRAUMATOL. VOLUME 58(3), PAGES 131-137(GERMANY) THIS STUDY AIMS TO DETERMINE IF DEFECTS CAUSED IN BENIGN SKELETAL LESIONS CAN BE TREATED WITH OSTEOCONDUCTIVE CERAMICS, AND WHETHER THESE TREATMENTS REGENERATE CANCELLOUS BONE SO THAT IT CAN WITHSTAND LOADS. A TOTAL OF 9 PATIENTS (6 FEMALES AND 3 MALES) WITH A MEAN AGE OF 45 YEARS (RANGE: 25- 65 YEARS) WITH BONE DEFECTS IN THE EPIPHYSIS AND METAPHYSIS OF LONG BONES WERE INCLUDED IN THE STUDY. AFTER REDUCTION OF FRACTURES SPACES WERE FILLED WITH MICRO-CHAMBERED BEADS MADE OF -TRICALCIUMPHOSPHATE (TCP) OR HYDROXYAPATITE (HA) OR A MIXTURE OF BOTH AND FIXED WITH THE APPROPRIATE OSTEOSYNTHESIS TO STABILIZE THE BONE. THE BEADS HAD A DIAMETER OF 4 AND 6 MM (CERABALL®,KARL STORZ ENDOSKOPE LLC & CO. KG, TUTTLINGEN, GERMANY). OSTEOSYNTHESIS PLATES (SYNTHES INC., FREIBURG, GERMANY) WERE USED IN ALL CASES OF FRACTURE. PATIENTS WERE FOLLOWED IN A PERIOD OF 22 MONTHS (RANGE: 7-48 MONTHS) AND A MINIMUM FOLLOW-UP OF 6 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: A CASE OF AN 87 YEAR OLD FEMALE DIED AFTER 8 MONTHS AND WHOSE LAST RADIOGRAPH TOOK PLACE AT 2 WEEKS. (EXCLUDED FROM THE STUDY). A CASE OF (B)(6) FEMALE HAD OSTEOPOROSIS. A CASE OF A (B)(6) FEMALE (PT NO. 6) WITH COMMINUTED CALCANEAL FRACTURES THE ANATOMY WAS RECONSTRUCTED, WITH A SATISFACTORY RESULT BEING OBTAINED IN 1 OF THE 2 CASES, WHICH FORMED NEW CANCELLOUS BONE, ALTHOUGH LEAVING A PERSISTENT DEFECT WITH A SCLEROTIC EDGE WHICH WAS VISIBLE IN BOTH PLANES . A CASE OF A (B)(6) MALE (PT NO. 5) WITH A HIGHLY COMMINUTED CALCANEAL FRACTURE (SANDERS TYPE IV) WAS NOT ANATOMICALLY REDUCED. THE HEALING PROCESS LEFT A SEVERE DEFORMITY AND A POOR CLINICAL OUTCOME (AOFAS SCORE OF 49). OPEN OSTEOTOMY, IN A (B)(6) PATIENT MALE (PATIENT NO. 9), WAS BILATERAL AND TREATED ON THE RIGHT SIDE WITH TCP BEADS AND A TOMOFIX®PLATE (MATHYS MEDIZINALTECHNIK AG, BETTLACH, SWITZERLAND), WITH INCOMPLETE FILLING OF THE BONE DEFECT. THE PATIENT BEGAN PARTIAL LOAD AT 2 WEEKS AND COMPLETE LOAD AT8 WEEKS. AT 15 MONTHS, RADIOGRAPHS REVEALED AN IRREGULAR CANCELLOUS BONE STRUCTURE ON THE RIGHT SIDE, INDICATING PERSISTENT DEFECTS IN THE ANTERIOR AND LATERAL PORTIONS, VISIBLE AT 21 MONTHS (FIG. 5). ANOTHER RECONSTRUCTION OF THE TIBIAL PLATEAU DID NOT PRODUCE THE EXPECTED RESULT (KSS SCORE OF 55), AS IT REVEALED A DEFORMITY ON THE PLATEAU REQUIRING FURTHER SURGERY. THIS REPORT IS FOR AN UNKNOWN SYNTHES TOMOFIX®PLATE. THIS REPORT CAPTURES A CASE OF (B)(6) PATIENT MALE (PATIENT NO. 9), TREATED ON THE RIGHT SIDE WITH TCP BEADS AND A TOMOFIX®PLATE WHO AT 15 MONTHS RADIOGRAPHS, REVEALED AN IRREGULAR CANCELLOUS BONE STRUCTURE ON THE RIGHT SIDE, INDICATING PERSISTENT DEFECTS IN THE ANTERIOR AND LATERAL PORTIONS, VISIBLE AT 21 MONTHS (FIG. 5). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 4 OF 5 FOR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771762 UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention