BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, FIXATION, INTRAMEDULLARY

    MDR report key: 7508645 · Received May 11, 2018

    Report

    Report Number
    8030965-2018-53720
    Event Type
    Injury
    Date Received
    May 11, 2018
    Report Date
    April 20, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE IS UNKNOWN DATE BETWEEN (B)(6) 2012 AND (B)(6) 2014. THIS REPORT IS FOR UNKNOWN TITANIUM ELASTIC NAILS/UNKNOWN LOTS. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBERS ARE UNKNOWN. IMPLANTATION AND EXPLANTATION DATES ARE 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: SHEN, K., XU, Y., CAO, D., WANG, Z. AND CAI, H. (2017) OUTCOME OF ANTEGRADE INTRAMEDULLARY FIXATION FOR JUVENILE FIFTH METACARPAL NECK FRACTURE WITH TITANIUM ELASTIC NAIL. EXPERIMENTAL AND THERAPEUTIC MEDICINE. VOLUME 13, PAGES 2997-3002. (CHINA). THIS PROSPECTIVE STUDY ASSESSES THE OUTCOME OF ANTEGRADE INTRAMEDULLARY FIXATION WITH TITANIUM ELASTIC NAIL (TEN) IN DISPLACED FIFTH METACARPAL NECK FRACTURES BETWEEN FEBRUARY 2012 AND JANUARY 2014. 69 JUVENILE PATIENTS (60 MALES AND 9 FEMALES AGED 12-17 YEARS) WITH FIFTH METACARPAL NECK FRACTURES RECEIVED SURGICAL INTERVENTION USING UNKNOWN SYNTHES 2.0MM PREFLEX TITANIUM ELASTIC NAIL. ALL SURGERY WAS PERFORMED UNDER GENERAL ANESTHESIA. ROUTINE ANTIBIOTICS WERE GIVEN POSTOPERATIVELY. PATIENTS WERE CLINICALLY FOLLOWED UP FROM SEVEN TO 37 MONTHS. COMPLICATIONS WERE REPORTED AS FOLLOWS: A (B)(6) YEAR OLD MALE EXPERIENCED DELAYED UNION. X-RAY IMAGES TAKEN AT 8 WEEKS POST-OPERATION DEMONSTRATED DELAYED UNION, BUT ACQUIRED GOOD HEALING AFTER 3 MONTHS, AT WHICH POINT THE NAIL WAS ALREADY REMOVED. FOUR CASES DEVELOPED NAIL TAIL IRRITATION BUT IT WAS TOLERATED AND DID NOT REQUIRE SPECIAL MANAGEMENT. THE SYMPTOMS DISAPPEARED WHEN THE INTERNAL FIXATION WAS REMOVED. THIS REPORT IS FOR AN UNKNOWN SYNTHES 2.0MM TITANIUM ELASTIC NAIL. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349952 ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention