BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, FIXATION, INTRAMEDULLARY

    MDR report key: 8688165 · Received June 11, 2019

    Report

    Report Number
    8030965-2019-65192
    Event Type
    Injury
    Date Received
    June 11, 2019
    Report Date
    May 15, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GROUP II CONSISTED OF 6 PATIENTS (1 MALE 5 FEMALE) WITH AN AVERAGE AGE AT THE BEGINNING OF THE TREATMENT WAS 4 (RANGE: 1.6-6.6) YEARS, WERE TREATED WITH VEPTR TECHNIQUE. 510K: THIS REPORT IS FOR AN UNKNOWN ROD/UNKNOWN LOT. PART AND LOT NUMBER 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. [(B)(4)].

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: ATICI, Y., AKMAN Y., BALIOGLU M., ERDOGAN S. (2015), A COMPARISON OF THE EFFECTS OF TWO DIFFERENT TECHNIQUES ON SHOULDER BALANCE IN THE TREATMENT OF CONGENITAL, JOURNAL OF CRANIOVERTEBRAL JUNCTION & SPINE (2015) VOLUME 6(4),PAGES 190-194 (TURKEY). THIS STUDY AIMS TO EVALUATE HOW THE TWO DIFFERENT GROWTH GUIDANCE TECHNIQUES RADIOLOGICALLY EFFECT ON SHOULDER BALANCE IN THE TREATMENT OF CONGENITAL SCOLIOSIS. BETWEEN 2004 TO 2011, A TOTAL OF 13 PATIENTS (2 MALE 7 FEMALE) WITH CONGENITAL SCOLIOSIS WHO UNDERWENT OPERATION WERE INCLUDED IN THE STUDY. THESE PATIENTS WERE DIVIDED INTO 2 GROUPS. GROUP I CONSISTED OF SEVEN PATIENTS (1 MALE 6 FEMALE) WITH AN AVERAGE AGE AT THE BEGINNING OF THE TREATMENT WAS 7.5 (RANGE: 4.6-10) YEARS, WERE TREATED WITH A DUAL GROWING ROD. GROUP II CONSISTED OF 6 PATIENTS (1 MALE 5 FEMALE) WITH AN AVERAGE AGE AT THE BEGINNING OF THE TREATMENT WAS 4 (RANGE: 1.6-6.6) YEARS, WERE TREATED WITH VEPTR TECHNIQUE. THE AVERAGE FOLLOW-UP PERIODS FOR GROUP 1 AND GROUP 2 WERE 4.2 (RANGE: 2-7) YEARS AND 4.7 (RANGE: 2-6) YEARS, RESPECTIVELY. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: GROUP 2: 5 OF THE 6 PATIENTS HAD THESE COMPLICATIONS CONSISTED OF: 3 CASES OF PROXIMAL CRADLE MIGRATIONS. 3 CASES OF DISTAL CRADLE MIGRATIONS. 2 CASES OF HOOK DISPLACEMENT. 2 CASES OF DEEP WOUND INFECTION. 1 CASE OF ROD FRACTURE. THIS REPORT IS FOR AN UNKNOWN ROD. THIS IS REPORT 6 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480151 ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention