BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 7666837 · Received July 6, 2018

    Report

    Report Number
    8030965-2018-54822
    Event Type
    Injury
    Date Received
    July 6, 2018
    Report Date
    June 11, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE PATIENTS. ALL KNOWN INFORMATION IS PRESENTED IN THE LITERATURE ARTICLE. THERE ARE MULTIPLE UNKNOWN DATES OF EVENT. 510K: THIS REPORT IS FOR AN UNKNOWN TRAUMA PLATE/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DATES OF IMPLANTATION ARE UNKNOWN DATES BETWEEN MAY 2012 TO DECEMBER 2014. IT IS UNKNOWN IF OR WHEN DEVICES WERE EXPLANTED. COMPLAINANT PARTS ARE 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 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. CODE (B)(4) USED TO CAPTURE LIMB ASYMMETRY. 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: EL-DESOUKY, IHAB. ET AL (2016), CLINICAL OUTCOME OF CONVENTIONAL VERSUS BIOLOGICAL FIXATION OF SUBTROCHANTERIC FRACTURES BY PROXIMAL FEMORAL LOCKED PLATE, INJURY - INTERNATIONAL JOURNAL OF THE CARE OF THE INJURED, VOL.47 (2016), PAGES 1309¿1317, (EGYPT). THE AIM OF THE PROSPECTIVE STUDY WAS TO EVALUATE THE CLINICAL OUTCOMES FOR THE FIXATION OF THE SUBTROCHANTERIC FEMORAL FRACTURES BY PROXIMAL FEMORAL-LOCKING COMPRESSION PLATE (PF-LCP) BY BOTH THE DIRECT (OPEN) AND THE INDIRECT (BIOLOGICAL) METHODS AND COMPARING THE RESULTS REGARDING THE SURGICAL DIFFERENCES, THE COMPLICATIONS AND THE FUNCTIONAL OUTCOME. BETWEEN MAY 2012 TO DECEMBER 2014, 46 PATIENTS (34 MALES AND 12 FEMALES WITH A MEAN AGE OF 44.3 YEARS) WITH SUBTROCHANTERIC FRACTURES WHO ARE MORE THAN 18 YEARS OF AGE AND WITH COMMINUTED FRACTURES OF SEINSHEIMER III, IV OR V WERE INCLUDED IN THE STUDY. 24 PATIENTS WERE SUBJECTED TO THE OPEN (DIRECT) FIXATION AND 22 PATIENTS WERE SUBJECTED TO THE BIOLOGICAL (INDIRECT) METHOD. ALL WERE IMPLANTED WITH AN UNKNOWN SYNTHES PROXIMAL FEMORAL-LOCKING COMPRESSION PLATE. PATIENTS WERE FOLLOWED AT 2, 6 WEEKS, 3 MONTHS, 6 MONTHS AND THEN TILL LAST FOLLOW-UP WITH THE FINAL FUNCTIONAL EVALUATION BY HARRIS HIP SCORE (HHS). THE FOLLOWING COMPLICATIONS INVOLVED PATIENTS WHO UNDERWENT OPEN FIXATION WITH PROXIMAL FEMORAL-LOCKING COMPRESSION PLATE (PF-LCP): A (B)(6) MALE PATIENT DIED AFTER 6 WEEKS. A (B)(6) FEMALE WITH SEINSHEIMER TYPE V FRACTURE AFTER A ROAD TRAFFIC ACCIDENT, EXPERIENCED BREAKAGE OF THE MOST PROXIMAL LOCKING SCREW WITHOUT LOSS OF THE POSITION DUE TO EARLY FULL WEIGHT BEARING AT EIGHT WEEKS. AFTER RESTRICTED WEIGHT BEARING, COMPLETE UNION OCCURRED IN 14 WEEKS WITHOUT ADDITIONAL INTERVENTION. THE FINAL HHS OF THIS PATIENT WAS GOOD. A (B)(6) WITH FRACTURE TYPE V SUFFERED DELAYED HEALING (MORE THAN 6 MONTHS = 24 WEEKS). THE FRACTURE UNITED WITHOUT ANY OTHER INTERFERENCE OR BONE GRAFTING. 3 PATIENTS HAD SUPERFICIAL WOUND INFECTION WHICH WAS CONTROLLED WITHIN EIGHT TO 10 DAYS BY DRESSING AND ANTIBIOTICS ACCORDING TO THE WOUND CULTURE AND SENSITIVITY. 1 PATIENT HAD DEEP WOUND INFECTION WHICH NEEDED DEBRIDEMENT AND WAS CONTROLLED BY INTRAVENOUS ANTIBIOTICS FOR TWO WEEKS. THE FINAL HHS WAS FAIR IN THIS PATIENT. TWO CASES, AGED MORE THAN 60 YEARS WITH FRACTURE TYPE IV, SUFFERED DELAYED HEALING (MORE THAN 6 MONTHS = 24 WEEKS). IN BOTH CASES, THE FRACTURE UNITED WITHOUT ANY OTHER INTERFERENCE OR BONE GRAFTING. TWO PATIENTS SUFFERED LIMB LENGTH DISCREPANCY LESS THAN 2 CM WITH VARUS ANGULATION LESS THAN 10 DEGREES BUT WITHOUT MAL-ROTATION. THE FOLLOWING COMPLICATIONS INVOLVED PATIENTS WHO UNDERWENT INDIRECT BIOLOGICAL FIXATION WITH PROXIMAL FEMORAL-LOCKING COMPRESSION PLATE (PF-LCP): A (B)(6) FEMALE PATIENT DIED ON THE 3RD POSTOPERATIVE DAY IN THE ICU DUE TO PULMONARY AND CHEST PROBLEMS. A (B)(6) MALE WITH SEINSHEIMER TYPE IIIB FRACTURE AFTER A ROAD TRAFFIC ACCIDENT EXPERIENCED FAILURE OF THE PLATE WHICH OCCURRED AFTER SIX WEEKS DUE TO SLIPPING AFTER ATTEMPTED FULL WEIGHT BEARING WITHOUT CONSULTATION. THE PATIENT ALSO EXPERIENCED DELAYED HEALING. THE FIXATION WAS REVISED BY ANOTHER LONGER PF-LCP PLATE WITHOUT GRAFTING. THE PATIENT WAS FOLLOWED TILL FULL HEALING AT 27 WEEKS. THE FINAL HHS OF THIS PATIENT WAS FAIR. A (B)(6) WITH FRACTURE TYPE IV HAD DELAYED HEALING WHICH WAS ACHIEVED AT 28 WEEKS WITHOUT INTERFERENCE. 2 PATIENTS HAD SUPERFICIAL WOUND INFECTION WHICH WAS CONTROLLED WITHIN EIGHT TO 10 DAYS BY DRESSING AND ANTIBIOTICS ACCORDING TO THE WOUND CULTURE AND SENSITIVITY. 1 OF THEM HAD A FINAL HHS OF FAIR. THREE PATIENTS SUFFERED LIMB LENGTH DISCREPANCY LESS THAN 2 CM WITH VARUS ANGULATION LESS THAN 10 DEGREES BUT WITHOUT MAL-ROTATION. THIS REPORT IS FOR AN UNKNOWN TRAUMA PLATE AND CAPTURES THE FOLLOWING ADVERSE EVENTS: OPEN FIXATION GROUP: 3 PATIENTS WHO HAD SUPERFICIAL WOUND INFECTION ; 1 PATIENT WHO HAD DEEP WOUND INFECTION ; TWO CASES OF DELAYED HEALING ; TWO PATIENTS WHO SUFFERED LIMB LENGTH DISCREPANCY WITH VARUS ANGULATION. INDIRECT BIOLOGICAL FIXATION GROUP: 2 PATIENTS WHO HAD SUPERFICIAL WOUND INFECTION IN WHICH 1 OF THEM HAD A FINAL HHS OF FAIR ; THREE PATIENTS WHO SUFFERED LIMB LENGTH DISCREPANCY WITH VARUS ANGULATION . THIS IS REPORT 5 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509088 PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention