BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5403862 · Received February 2, 2016

    Report

    Report Number
    2520274-2016-10640
    Event Type
    Injury
    Date Received
    February 2, 2016
    Report Date
    January 8, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RUCH, D.S., ET AL (2010). CORRECTIVE OSTEOTOMY FOR ISOLATED MALUNION OF THE PALMAR LUNATE FACET IN DISTAL RADIUS FRACTURES. J HAND SURG. 35(11), 1779-1786. THIS REPORT IS FOR AN UNKNOWN NON-LOCKING PALMAR BUTTRESS PLATE. (B)(4) PERSISTENT CREPITUS AT THE WRIST AND ADHERENT FLEXOR DIGITORUM PROFUNDUS TENDON. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, RUCH, D.S., ET AL (2010). CORRECTIVE OSTEOTOMY FOR ISOLATED MALUNION OF THE PALMAR LUNATE FACET IN DISTAL RADIUS FRACTURES. J HAND SURG. 35(11), 1779-1786. US ARTICLE. THE GOAL OF THIS STUDY WAS TO DESCRIBE THE CLINICAL AND RADIOGRAPHIC OUTCOMES AFTER CORRECTIVE OSTEOTOMY FOR ISOLATED MALUNION OF THE PALMAR LUNATE FACET. BETWEEN 1995 AND 2000, A RETROSPECTIVE REVIEW IDENTIFIED 13 PATIENTS (EIGHT MEN; FIVE WOMEN) WITH AN AVERAGE AGE OF 44 YEARS (RANGE, 23-57 YEARS). THE AUTHORS PERFORMED DEFINITIVE FIXATION USING A SYNTHES STANDARD NON-LOCKING PALMAR BUTTRESS PLATE IN 6 PATIENTS AND A SYNTHES 2.4-MM DISTAL RADIUS JUXTA-ARTICULAR LOCKING PLATE IN 7 PATIENTS. THERE WERE NO INTRAOPERATIVE COMPLICATIONS NOTED. OF THE 13 PATIENTS IN THIS STUDY, SEVEN REQUIRED HARDWARE REMOVAL AFTER UNION OF THE PALMAR LUNATE FACET FRAGMENT. INDICATIONS FOR THIS HARDWARE REMOVAL WERE PERSISTENT CREPITUS AT THE WRIST IN 5 PATIENTS, FAILURE TO REGAIN WRIST EXTENSION IN 1 PATIENT, AND AN ADHERENT FLEXOR DIGITORUM PROFUNDUS TENDON IN 1 PATIENT. THIS REPORT IS FOR AN UNKNOWN NON-LOCKING PALMAR BUTTRESS PLATE AND REFERS TO THE SEVEN PATIENTS WHO REQUIRED HARDWARE REMOVAL AFTER UNION OF THE PALMAR LUNATE FACET FRAGMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62190 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention