BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 8808423 · Received July 19, 2019

    Report

    Report Number
    8030965-2019-66420
    Event Type
    Injury
    Date Received
    July 19, 2019
    Date of Event
    February 1, 2012
    Report Date
    June 26, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN UNK - PLATES: TRAUMA/UNKNOWN LOT NUMBER. WITHOUT THE SPECIFIC PART NUMBER, THE UDI NUMBER AND 510K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). THE REPORTED EVENT REQUIRED MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION SUMMARY COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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, 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: OE, K. ET AL (2012), OPERATIVE MANAGEMENT OF PERIARTICULAR MEDIAL CLAVICLE FRACTURES¿REPORT OF TEN CASES, THE JOURNAL OF TRAUMA AND ACUTE CARE SURGERY, VOL. 72 (2), PAGES E1-E7 (GERMANY). THE AIM OF THIS RETROSPECTIVE STUDY IS TO ANALYZE THE OPERATIVE TREATMENT OF PERIARTICULAR, MEDIAL CLAVICLE FRACTURES AT THE TRAUMA CENTER MURNAU. BETWEEN JANUARY 2004 TO JULY 2009, A TOTAL OF 10 PATIENTS (9 MALES AND 1 FEMALE), WITH A MEAN AGE OF 33.9 YEARS, WERE INCLUDED IN THE STUDY. OF THESE, ONLY 9 PATIENTS WERE TREATED WITH EITHER OF THE FOLLOWING: 2.7- TO 3.5-MM SMALL FRAGMENT LOCKING PLATES, 2.7-MM LCP COMPACT FOOT PLATE, LCP RECONSTRUCTION PLATE, MODIFIED LCP PILON PLATE, OR DYNAMIC COMPRESSION PLATE (DCP) (SYNTHES, INC.). THE MEAN FOLLOW-UP TIME WAS 38 MONTHS (RANGE, 14¿52 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: A (B)(6) YEAR-OLD MALE PATIENT HAD PLATE LOOSENING (PILON PLATE, NON-LOCKING SCREWS WERE USED), SCREWS BACKED OUT AND SUPERFICIAL WOUND INFECTION 5 DAYS AFTER SURGERY. THE PLATE WAS REMOVED, AND THE OPERATIVE SITE WAS TREATED USING DEBRIDEMENT AND IRRIGATION. THE POSTOPERATIVE COURSE REMAINED WITHOUT COMPLICATIONS, AND THE WOUND REMAINED DRY AND UNREMARKABLE. A (B)(6) YEAR-OLD MALE PATIENT WAS EXCLUDED FROM CONSECUTIVE EVALUATION DUE TO SEVERE SPINAL CORD INJURY WITH TETRAPLEGIA/PARAPLEGIA. THE FRACTURE HEALED, THE PATIENT DID NOT HAVE PAIN AND WERE SATISFIED WITH THE OPERATIVE RESULT. A (B)(6) YEAR-OLD MALE PATIENT WAS EXCLUDED FROM CONSECUTIVE EVALUATION DUE TO SEVERE SPINAL CORD INJURY WITH TETRAPLEGIA/PARAPLEGIA. THE FRACTURE HEALED, THE PATIENT DID NOT HAVE PAIN AND WERE SATISFIED WITH THE OPERATIVE RESULT. IN ONE CASE OF A YOUNG BOY, EARLY REMOVAL AFTER 5 MONTHS WAS THE RESULT OF LOCAL IRRITATION, BEFORE OPERATION FRACTURE UNION WAS CONFIRMED BY CT SCAN (THE ARTICLE DID NOT INDICATE SPECIFIC IMPLANT USED). THESE IMPACTED PRODUCTS CAPTURE THE REPORTED CASE OF A YOUNG BOY WHO HAD LOCAL IRRITATION AND HARDWARE WAS REMOVED (THE ARTICLE DID NOT INDICATE WHAT IMPLANTS WERE USED. THIS REPORT IS FOR AN UNKNOWN SYNTHES PLATES. THIS REPORT IS 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601615 PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention