BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PLATE/SCREWS

    MDR report key: 11494186 · Received March 16, 2021

    Report

    Report Number
    8030965-2021-01998
    Event Type
    Injury
    Date Received
    March 16, 2021
    Report Date
    February 17, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: PLATE/SCREWS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI 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

    DEVICE REPORT FROM SYNTHESIS REPORTS AN EVENT IN TOGO AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: ABALO, A. ET AL. (2008), DYNAMIC HIP SCREW AND COMPRESSION PLATE FIXATION OF IPSILATERAL FEMORAL NECK AND SHAFT FRACTURES, JOURNAL OF ORTHOPAEDIC SURGERY VOL. 16(1), PAGES 35-38 (TOGO) THE PURPOSE OF THIS STUDY IS TO EVALUATE SURGICAL OUTCOMES OF IPSILATERAL FEMORAL NECK AND SHAFT FRACTURES. BETWEEN APRIL 1997 AND SEPTEMBER 2004, 29 MALES AND 8 FEMALES WITH A MEAN AGE OF 37 YEARS UNDERWENT FIXATION OF FEMORAL NECK AND SHAFT FRACTURES USING A DYNAMIC COMPRESSION PLATE PLUS A DYNAMIC HIP SCREW OR SCREWS. ALL DISPLACED NECK FRACTURES WERE OPENLY REDUCED USING THE WATSON-JONES APPROACH WITH 2 TO 3 LAG SCREWS (IN 12 PATIENTS) OR BY A DHS (IN 25 PATIENTS). FEMORAL SHAFT FRACTURES WERE FIXED BY A 10-HOLE TO 16- HOLE DCP. WHEN THE SHAFT FRACTURES WERE VERY PROXIMAL (IN 6 PATIENTS), THE PLATE WAS PLACED IN A MORE ANTERIOR POSITION OR A 2-HOLE PLATE WAS USED FOR THE DHS. THE MEAN FOLLOW-UP PERIOD WAS 49 MONTHS. THE ARTICLE DID NOT SPECIFY WHICH OF THE DEVICES WERE BEING USED TO CAPTURE THE FOLLOWING COMPLICATIONS: FEMORAL NECK FRACTURES: 1 PATIENT HAD A 6º VARUS ANGULATION. 3 PATIENTS HAD A NONUNION (ONE REFUSED REVISION SURGERY AND 2 UNDERWENT VALGUS INTERTROCHANTERIC OSTEOTOMY AND HEALED 3.6 AND 3.9 MONTHS LATER). FEMORAL SHAFT FRACTURES: 5 PATIENTS HAD NONUNION (2 PERSISTED EVEN FOLLOWING REVISION SURGERY AND ILIAC BONE GRAFTINGAFTER CHANGING THE DCP). 7 PATIENTS DEVELOPED INFECTIONS (5 SUPERFICIAL AND 2 DEEP) AND RESOLVED FOLLOWING DEBRIDEMENT AND ANTIBIOTIC TREATMENT. A (B)(6) YEAR-OLD FEMALE PATIENT WHO UNDERWENT DCP AND DHS HAD A POOR FUNCTIONAL RESULT. A (B)(6) YEAR-OLD FEMALE PATIENT WHO UNDERWENT DCP AND DHS HAD A FAIR FUNCTIONAL RESULT. A (B)(6) YEAR-OLD MALE PATIENT WHO UNDERWENT DCP AND DHS HAD A POOR FUNCTIONAL RESULT. A (B))(6) YEAR-OLD MALE PATIENT WHO UNDERWENT DCP AND DHS HAD A POOR FUNCTIONAL RESULT. A (B)(6) YEAR-OLD MALE PATIENT WHO UNDERWENT DCP AND DHS HAD A FAIR FUNCTIONAL RESULT. A (B)(6) YEAR-OLD MALE PATIENT WHO UNDERWENT DCP AND DHS HAD A FAIR FUNCTIONAL RESULT. A (B)(6) YEAR-OLD MALE PATIENT WHO UNDERWENT DCP HAD A FAIR FUNCTIONAL RESULT. A (B)(6) YEAR-OLD FEMALE PATIENT WHO UNDERWENT DCP AND DHS HAD A FAIR FUNCTIONAL RESULT. THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: PLATE/SCREWS. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 2 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390041 UNK - CONSTRUCTS: PLATE/SCREWS PLATE, FIXATION ,BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention