BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 7679400 · Received July 11, 2018

    Report

    Report Number
    8030965-2018-54946
    Event Type
    Injury
    Date Received
    July 11, 2018
    Report Date
    June 14, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE PATIENTS. ALL KNOWN INFORMATION IS PROVIDED IN THE LITERATURE ARTICLE. THERE ARE MULTIPLE UNKNOWN DATES OF EVENT SUBSEQUENT TO (B)(6) 2008. THE 510K: THIS REPORT IS FOR UNKNOWN TRAUMA SCREWS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DATE OF IMPLANTATION IS UNKNOWN DATE BETWEEN JANUARY 2008 AND MAY 2010. IT IS UNKNOWN IF OR WHEN DEVICES WERE EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER PHONE NUMBER IS UNKNOWN. 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. (B)(4) USED TO CAPTURE REQUIRED SURGICAL INTERVENTION. 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: HU S, ZHANG S, GUANGRONG YU (2012). TREATMENT OF FEMORAL SUBTROCHANTERIC FRACTURES WITH PROXIMAL LATERAL FEMUR LOCKING PLATES. ACTA ORTOPEDICA BRASILEIRA. VOLUME 20. NUMBER 6. PAGES 329-333. (CHINA). THE PURPOSE OF THIS RETROSPECTIVE STUDY IS TO EVALUATE THE OUTCOME OF SUBTROCHANTERIC HIP FRACTURES TREATED WITH PROXIMAL LATERAL FEMUR LOCKING PLATE. BETWEEN JANUARY 2008 AND MAY 2010, 48 PATIENTS WITH SUBTROCHANTERIC FRACTURES WHO UNDERWENT SURGICAL INTERVENTION FOR FRACTURE REDUCTION WERE INCLUDED IN THE STUDY. THE MEAN AGE OF THE PATIENTS WAS 76 YEARS (RANGE 43 TO 85 YEARS). PATIENTS WERE IMPLANTED WITH AN UNKNOWN SYNTHES PROXIMAL LATERAL FEMUR LOCKING COMPRESSION PLATE (PFLCP). AMONG 48 PATIENTS WHO UNDERWENT SURGERY, 2 PATIENTS WERE LOST TO FOLLOW-UP AND 1 PATIENT DIED THREE WEEKS AFTER THE OPERATION. THE REMAINING 45 PATIENTS WERE FOLLOWED UNTIL FRACTURE UNION OR REVISION SURGERY FOR AN AVERAGE OF 16 MONTHS (RANGE 6 TO 28 MONTHS). COMPLICATIONS WERE REPORTED AS FOLLOWS: ONE PATIENT DIED 3 WEEKS POST-OP. REASONS FOR DEATH WERE PNEUMONIA AND CONGESTIVE HEART FAILURE, WHICH WERE NOT RELATED TO THE SURGICAL INTERVENTION OR THE IMPLANT. ONE PATIENT HAD SEVERE INFECTION POST-OP WHICH WAS CURED BY DEBRIDEMENT AND INTRAVENOUS DRIP OF VANCOMYCIN. THREE PATIENTS HAD SUPERFICIAL INFECTION AND CURED BY ORAL ANTIBIOTIC THERAPY AND DRESSING CHANGES. TWO PATIENTS HAD IMPLANT FAILURE AND UNDERWENT REVISION SURGERY. THE REASON FOR IMPLANT FAILURE WAS THAT THE TWO PATIENTS STARTED BEARING WEIGHT 4 WEEKS AFTER SURGERY. FIVE PATIENTS HAD MEDIAN SCORE ACCORDING TO HARRIS SOCIAL INDEX. TWO PATIENTS HAD FEMORAL NECK SCREW BREAKAGE AT 3 MONTHS POST-OP BUT THE FRACTURE HEALED AFTER DELAYING THE WEIGHT BEARING TIME. THIS REPORT IS FOR UNKNOWN TRAUMA SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4). .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519246 SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention