BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4622651 · Received March 23, 2015

    Report

    Report Number
    2520274-2015-11958
    Event Type
    Injury
    Date Received
    March 23, 2015
    Report Date
    February 27, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECKER, T., WEIGL. D., MERCADO, E., KATZ, K., AND BAR-ON, E. (2012), FRACTURES AND REFRACTURES AFTER FEMORAL LOCKING COMPRESSION PLATE FIXATION IN CHILDREN AND ADOLESCENTS. J PEDIATR ORTHOP. 32 (7), E40-46. THIS REPORT IS FOR AN UNKNOWN PLATE. 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, BECKER, T., WEIGL. D., MERCADO, E., KATZ, K., AND BAR-ON, E. (2012), FRACTURES AND REFRACTURES AFTER FEMORAL LOCKING COMPRESSION PLATE FIXATION IN CHILDREN AND ADOLESCENTS. J PEDIATR ORTHOP. 32 (7), E40-46. THE GOAL OF THIS STUDY WAS TO ANALYZE FAILURE PATTERNS ASSOCIATED WITH LOCKING COMPRESSION PLATES (LCPS) AND IDENTIFY POSSIBLE CONTRIBUTING FACTORS. THE SAMPLE INCLUDED ALL PATIENTS WHO UNDERWENT FIXATION OF FEMORAL FRACTURES OR OSTEOTOMIES UTILIZING A SYNTHES STRAIGHT 4.5 MM NARROW TITANIUM LCP AT A TERTIARY PEDIATRIC MEDICAL CENTER FROM 2004 TO 2009. THIRTY-SEVEN PATIENTS UNDERWENT 41 STRAIGHT LCP FIXATIONS DURING THE STUDY PERIOD. THE INDICATION FOR SURGERY WAS ACUTE FEMORAL FRACTURE IN 25 PROCEDURES (25 PATIENTS) AND ELECTIVE OSTEOTOMY OR LIMB LENGTHENING IN 16 PROCEDURES (12 PATIENTS). THE STUDY SAMPLE INCLUDED 25 MALE AND 12 FEMALE PATIENTS AGED 5 TO 16 YEARS. AVERAGE AGE AT INDEX SURGERY WAS 11.5 YEARS (RANGE, 6 TO 16 Y) IN THE FRACTURE GROUP AND 9.3 YEARS (RANGE, 1 TO 16 Y) IN THE OSTEOTOMY GROUP. ALL WERE FOLLOWED TO UNION. ONE PATIENT, A MULTITRAUMA CASE INVOLVING IPSILATERAL FEMUR AND TIBIAL FRACTURES, REQUIRED REVISION OF THE FEMORAL PLATE 24 HOURS AFTER INDEX SURGERY BECAUSE OF MALREDUCTION. ONE PATIENT, A (B)(6) FEMALE, SUSTAINED A FRACTURE OF THE FEMUR WITH BREAKAGE OF THE PLATE 9 WEEKS AFTER THE INDEX SURGERY FOR FEMUR FRACTURE. REVISION TREATMENT CONSISTED OF PLATE REMOVAL AND REFIXATION USING AN INTRAMEDULLARY NAIL (IMN). FOLLOW-UP INDICATED COMPLETE HEALING WITH NO FURTHER COMPLICATIONS. ANOTHER PATIENT, (B)(6) FEMALE, WITH UNDERLYING RENAL OSTEODYSTROPHY SUSTAINED A FEMORAL FRACTURE AT THE PROXIMAL LOCKING SCREW 6 WEEKS AFTER PRIMARY SURGERY FOR CORRECTION OF A DEFORMITY. REPEATED SURGERY WITH A LONGER LCP WAS FOLLOWED BY UNEVENTFUL HEALING AND NO FURTHER COMPLICATIONS TO PLATE REMOVAL OR THEREAFTER. THIS REPORT IS FOR AN UNKNOWN LOCKING COMPRESSION PLATE AND REFERS TO THE SERIOUS INJURY / REPORTABLE MALFUNCTION OF A (B)(6) FEMALE WHO SUSTAINED A FRACTURE OF THE FEMUR WITH BREAKAGE OF THE PLATE 9 WEEKS AFTER THE INDEX SURGERY FOR FEMUR FRACTURE. REVISION TREATMENT CONSISTED OF PLATE REMOVAL AND REFIXATION USING AN IMN. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193175 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention