BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5089477 · Received September 18, 2015

    Report

    Report Number
    2520274-2015-15960
    Event Type
    Injury
    Date Received
    September 18, 2015
    Date of Event
    July 12, 2006
    Report Date
    September 14, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN TITANIUM 4.5-MM LOCKING COMPRESSION PLATE/UNKNOWN QUANTITY/UNKNOWN LOT. (B)(4). SUBCUTANEOUS INFECTION WAS DIAGNOSED, LEADING TO AN EARLY ELECTIVE PLATE REMOVAL 3 MONTHS AFTER SURGERY. IN THREE PATIENTS, SUBCHONDRAL SCLEROSIS AND OSTEOPHYTIC BONE GROWTH WERE RADIOLOGICALLY DIAGNOSED 1 YEAR POSTOPERATIVELY AND WERE SEEN AS SIGNS OF A POST-TRAUMATIC ARTHROSIS. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICES WERE RETURNED AND NO LOT NUMBERS OR PART NUMBERS WERE PROVIDED. 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 SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: HUBER, F. ET AL. (2006). VOID FILLING OF TIBIA COMPRESSION FRACTURE ZONES USING A NOVEL RESORBABLE NANOCRYSTALLINE HYDROXYAPATITE PASTE IN COMBINATION WITH A HYDROXYAPATITE CERAMIC CORE: FIRST CLINICAL RESULTS. ARCH ORTHOP TRAUMA SURG, 126, 533-540. THE AIM OF OUR STUDY WAS A PROSPECTIVE FUNCTIONAL AND RADIOLOGICAL EVALUATION OF THE APPLICATION OF A REABSORBABLE NANOCRYSTALLINE PASTE IN COMBINATION WITH A SOLID HYDROXYAPATITE CERAMIC CORE FOR THE TREATMENT OF ARGE METAPHYSEAL DEFECTS FOLLOWING REDUCTION OF TIBIA COMPRESSION FRACTURES. BETWEEN OCTOBER 2002 AND MAY 2004, 24 PATIENTS (9 WOMEN AND 15 MEN) WITH TIBIA HEAD COMPRESSION FRACTURES WERE TREATED BY COMBINING THE USE OF THE HYDROXYAPATITE PASTE WITH THE HYDROXYAPATITE CERAMIC CORE. THE ANATOMIC REDUCTION WAS ALSO SUPPORTED WITH A PLATE SYSTEM, A TITANIUM 4.5-MM LOCKING COMPRESSION PLATE (SYNTHES (B)(4)). COMPLICATIONS INCLUDED: IN THREE PATIENTS, A DELAYED WOUND HEALING WAS OBSERVED AS A LOCAL COMPLICATION, WITH A SEROUS SECRETION LASTING 2 WEEKS IN EACH CASE. IN ANOTHER CASE, A SUBCUTANEOUS INFECTION WAS DIAGNOSED, LEADING TO AN EARLY ELECTIVE PLATE REMOVAL 3 MONTHS AFTER SURGERY. IN THREE PATIENTS, SUBCHONDRAL SCLEROSIS AND OSTEOPHYTIC BONE GROWTH WERE RADIOLOGICALLY DIAGNOSED 1 YEAR POSTOPERATIVELY AND WERE SEEN AS SIGNS OF A POST-TRAUMATIC ARTHROSIS. PATIENTS ALSO EXPERIENCED PAIN, OCCASIONAL ACHE, AND LACK OF EXTENSION. THIS REPORT IS FOR AN UNKNOWN TITANIUM 4.5-MM LOCKING COMPRESSION PLATE. A COPY OF THE LITERATURE ARTICLE IS ATTACHED TO THE MEDWATCH. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618933 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention