BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5024529 · Received August 24, 2015

    Report

    Report Number
    2520274-2015-15403
    Event Type
    Injury
    Date Received
    August 24, 2015
    Report Date
    August 14, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: JUNG, S., KIM, H., LEE, J., LIM, H., SHIM, S. (2014). FACTORS THAT INFLUENCE REDUCTION LOSS IN PROXIMAL HUMERUS FRACTURE SURGERY. J ORTHOP TRAUMA , 29, 276¿282. THIS REPORT IS FOR AN UNKNOWN PROXIMAL HUMERAL INTERNAL LOCKING SYSTEM /UNKNOWN QUANTITY/UNKNOWN LOT. ADDITIONAL DEVICE PRODUCT CODE: HWC, COMMON DEVICE NAME: SCREW, FIXATION, BONE. PATIENT CODES: REFERES TO SCREW LOOSENING. 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. 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 THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE JUNG, S., KIM, H., LEE, J., LIM, H., SHIM, S. (2014). FACTORS THAT INFLUENCE REDUCTION LOSS IN PROXIMAL HUMERUS FRACTURE SURGERY. J ORTHOP TRAUMA , 29, 276-282. THIS RETROSPECTIVE STUDY WAS PERFORMED TO IDENTIFY THE RISK FACTORS FOR REDUCTION LOSS AFTER LOCKING PLATE FIXATION OF PROXIMAL HUMERUS FRACTURES. 252 PATIENTS WERE EVALUATED OF WHICH 49 WERE MEN AND 203 WERE WOMEN WHO HAD BEEN SURGICALLY TREATED FOR PROXIMAL HUMERAL FRACTURES WITH LOCKING PLATES BETWEEN (B)(6) 2004 AND (B)(6) 2011. THE AVERAGE AGE OF THE PATIENTS WAS 62.1 (RANGE, 25-92) YEARS. THE PATIENTS WERE DIVIDED INTO 2 GROUPS; THE REDUCTION LOSS GROUP AND THE REDUCTION MAINTENANCE GROUP. COMPLICATIONS: 20 PATIENTS HAD IMPLANT-RELATED PROBLEMS SUCH AS (SCREW PERFORATION, PLATE IMPINGEMENT, CUT-OUT, CUT-THROUGH, PLATE FAILURE). 5 PATIENTS HAD AVASCULAR NECROSIS. 5 HAD NON-UNIONS. 3 PATIENTS HAD AXILLARY INJURY. 3 PATIENTS HAD INFECTIONS. REDUCTION LOSS WAS OBSERVED IN THE FOLLOW-UP X-RAYS OF 17 OF 252 PATIENTS, AN OVERALL RATE OF REDUCTION LOSS OF 6.7%. AMONG THESE 17 PATIENTS, 13 UNDERWENT CONVERSION SURGERY TO ARTHROPLASTY AND 4 UNDERWENT REVISION SURGERY FOR PLATE REFIXATION AND AUTOGENOUS BONE GRAFT FROM THE PELVIC ILIUM. ACUTE REDUCTION LOSS OCCURRED WITHIN 1 MONTH AFTER SURGERY IN 15 CASES, AND LATE REDUCTION LOSS WITH SCREW PERFORATION OR LOOSENING OCCURRED AT 3-6 MONTHS AFTER SURGERY IN 2 CASES. ((B)(6) FEMALE), WITH A 2-PART, A3 FRACTURE. THE PATIENT HAD VARUS DISPLACEMENT . REDUCTION LOSS WAS SEEN AT 2 WEEKS POSTOPERATIVELY AND PROGRESSED TO COLLAPSE. ((B)(6) FEMALE), WITH A 2-PART, B2 FRACTURE. THE PATIENT HAD VARUS DISPLACEMENT AND MEDIAL COMMINUTION. REDUCTION LOSS WAS SEEN AT 2 WEEKS POSTOPERATIVELY AND PROGRESSED TO COLLAPSE. A COPY OF THE LITERATURE ARTICLE IS ATTACHED TO THIS MEDWATCH. THIS IS REPORT 4 OF 5 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN PROXIMAL HUMERAL INTERNAL LOCKING SYSTEM AND REFERS TO LATE REDUCTION LOSS WITH SCREW PERFORATION OR LOOSENING OCCURRED AT 3-6 MONTHS AFTER SURGERY IN 2 CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557436 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention