BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 8571317 · Received May 1, 2019

    Report

    Report Number
    8030965-2019-63364
    Event Type
    Injury
    Date Received
    May 1, 2019
    Date of Event
    June 10, 2009
    Report Date
    April 4, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME, COMMON DEVICE NAME, PROCODE, MFR, LOT #, PART #, UDI #, 510K: THIS REPORT IS FOR AN UNKNOWN LOCKING COMPRESSION PLATES (LCP)/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). DEVICE EVALUATED BY MFR, MANUFACTURE DATE: 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: AYERZA, M. ET AL (2009), "JOINT PRESERVATION AFTER EXTENSIVE CURETTAGE OF KNEE GIANT CELL TUMORS." CLINICAL ORTHOPAEDICS AND RELATED RESEARCH, VOL. 467, PAGES 2845-2851 (ARGENTINA). THE PURPOSE OF THIS STUDY IS TO PRESERVE THE FUNCTION OF THE JOINT AN TO SURGICALLY TREAT THE GIANT CELL TUMOR. BETWEEN JULY 2002 AND AUGUST 2006, A TOTAL 22 PATIENTS (16 MALE AND 6 FEMALE) WITH AN AVERAGE MEAN AGE OF 31 YEARS (RANGE 17-66 YEARS) WERE INCLUDED IN THIS STUDY. PATIENTS UNDERWENT KNEE RECONSTRUCTION WITH A COMBINATION OF CANCELLOUS BONE AND STRUCTURAL ALLOGRAFT AFTER RESECTION OF A GCT. THE DIAGNOSIS WAS CONFIRMED BY PREOPERATIVE FINE-NEEDLE PERCUTANEOUS BIOPSY. ALL RECONSTRUCTIONS WERE PERFORMED AFTER AN INTRALESIONAL RESECTION OF A PRIMARY (19 CASES) OR RECURRENT GCT (THREE CASES). 12 WERE DISTAL FEMUR AND 10 PROXIMAL TIBIA RECONSTRUCTIONS. THE MEAN FOLLOW-UP WAS 24 MONTHS (AVERAGE, 48 MONTHS; RANGE 24-80 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT HAD MINIMAL SUBCHONDRAL COLLAPSE WITHOUT JOINT NARROWING. 1 PATIENT HAD A SOFT TISSUE RECURRENCE WITH RESECTION BUT DID NOT REQUIRE REMOVAL OF THE ALLOGRAFT. TWO OF THE 22 RECONSTRUCTIONS WERE REMOVED AS A RESULT OF LOCAL RECURRENCES. ONE WAS A PROXIMAL TIBIA AT 13 MONTHS AFTER. SURGERY AND THE OTHER A DISTAL FEMUR RECONSTRUCTION AT 44 MONTHS AFTER SURGERY. BOTH RECURRENCES WERE LOCATED IN METAPHYSEAL BONE. THIS REPORT CAPTURES ONE PATIENT WHO EXPERIENCED SUBCHONDRAL COLLAPSE, ONE PATIENT WHO EXPERIENCED SOFT TISSUE RECURRENCE, AND 2 PATIENTS WHO REQUIRED IMPLANT REMOVED. THIS REPORT IS FOR A LOCKING COMPRESSION PLATES (LCP). THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364192 PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention