BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE,FIXATION,BONE

    MDR report key: 7906852 · Received September 25, 2018

    Report

    Report Number
    8030965-2018-56633
    Event Type
    Injury
    Date Received
    September 25, 2018
    Report Date
    August 31, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED FOR REPORTING. DATE OF EVENT IS UNKNOWN. THIS REPORT IS FOR UNKNOWN PLATES. PART#, LOT# AND UDI # IS NOT AVAILABLE. IMPLANTED, EXPLANTED DATE: UNKNOWN. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THIS REPORT IS FOR UNKNOWN PLATES. PMA/510(K) NUMBER IS NOT AVAILABLE. ADDITIONAL MEDICAL/SURGICAL INTERVENTION REQUIRED. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. ADDITIONALLY, DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. 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: BALTES TPA, DONDERS JCE, KLOEN P (2017). WHAT IS THE HARDWARE REMOVAL RATE AFTER ANTEROINFERIOR PLATING OF THE CLAVICLE? A RETROSPECTIVE COHORT STUDY JOURNAL OF SHOULDER AND ELBOW SURGERY. VOLUME 26. PAGES 1838-1843. (THE NETHERLANDS). THE PURPOSE OF THIS STUDY WAS THEREFORE TO DESCRIBE THE LONG-TERM HARDWARE REMOVAL RATE AFTER ANTEROINFERIOR PLATING OF THE CLAVICLE. BETWEEN FEBRUARY 2003 AND JULY 2015, 53 PATIENTS (54 CLAVICLES) WITH CLAVICLE FRACTURES, DELAYED UNIONS, OR NONUNIONS WHO UNDERWENT TREATMENT WITH AN ANTEROINFERIOR PLATE FIXATION, WERE INCLUDED IN THE STUDY. PATIENTS WERE IMPLANTED WITH EITHER AN UNKNOWN SYNTHES TITANIUM 3.5-MM LOCKING COMPRESSION PELVIC RECONSTRUCTION PLATE OR AN UNKNOWN SYNTHES 2.7-MM DYNAMIC COMPRESSION PLATE (USED IN 1 PATIENT). IN SELECTED CASES, AN UNKNOWN MANUFACTURER 3.5-MM CORTICAL LAG SCREW WAS PLACED THROUGH THE PLATE THROUGH THE OBLIQUITY OF THE NONUNION OR FRACTURE. FIXATION CONSISTED OF 3 OR 4 UNKNOWN SYNTHES SCREWS (MOST OFTEN, STANDARD NONLOCKING SCREWS) ON EITHER SIDE. PATIENTS REQUIRED A MINIMUM AGE OF 16 YEARS AT TIME OF SURGERY AND A FOLLOW-UP OF GREATER THAN 12 MONTHS. THERE WERE 37 MALE PATIENTS. THE MEAN FOLLOW-UP DURATION WAS 6.4 YEARS (RANGE, 1.1 TO 13.1 YEARS). THE MEAN AGE AT FOLLOW-UP WAS 47.8 YEARS (RANGE, 20.4 TO 80.7 YEARS). COMPLICATIONS WERE REPORTED AS FOLLOWS: (THE ARTICLE DID NOT SPECIFY WHICH TYPE OF PLATES IMPLANTED WITH THE PATIENTS INVOLVED.) THREE PATIENTS HAD REQUESTED HARDWARE REMOVAL DUE TO PLATE PROMINENCE. THREE PATIENTS HAD PLATE BREAKAGE THAT OCCURRED AS A RESULT OF NONUNION. TWO OF THESE PATIENTS UNDERWENT REVISION PLATING AND BONE GRAFTING WHILE ONE OF THEM IS A FEMALE PATIENT WHO HAD AN UNEXPECTED POSITIVE CULTURE FOR PROPIONIBACTERIUM ACNES AND WAS TREATED WITH REVISION FIXATION, BONE GRAFTING AND ORAL ANTIBIOTICS. ALL 3 EVENTUALLY HEALED. THIS REPORT IS FOR THREE (3) DEVICES- UNKNOWN SYNTHES TITANIUM 3.5-MM LOCKING COMPRESSION PELVIC RECONSTRUCTION PLATE, UNKNOWN SYNTHES 2.7-MM DYNAMIC COMPRESSION PLATE, UNKNOWN SYNTHES SCREWS. THIS REPORT IS FOR UNKNOWN PLATES FOR: IMPLANT REVISION DUE TO PLATE BREAKAGE RESULTING FROM NONUNION. THIS IS REPORT 2 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745903 PLATE,FIXATION,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention