BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRS MULTIPLANAR CLAMP

    MDR report key: 2338146 · Received November 10, 2011

    Report

    Report Number
    9680825-2011-00013
    Event Type
    Injury
    Date Received
    November 10, 2011
    Date of Event
    July 1, 2011
    Report Date
    November 9, 2011
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JDW
    PMA / PMN Number
    K955848
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A TECHNICAL EVALUATION OF THE PRODUCT USED WAS NOT PERFORMED AS THE PRODUCT HAS NOT YET MADE AVAILABLE FOR THE INVESTIGATION. THE ORIGINAL BATCH, MANUFACTURED IN 2009, WAS COMPRISED (B)(4) PIECES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED ON THE MARKET. NO OTHER FAILURES HAVE BEEN REPORTED FORM THIS LOT. THE CLINICAL EVALUATION, PERFORMED BY AN EXTERNAL MEDICAL EVALUATOR AND BASED ON THE X-RAYS RECENTLY MADE AVAILABLE, EVIDENCES AS FOLLOWS: "THE PATIENT HAS A MARKED VARUS OF THE LEFT LEG WITH SOME SHORTENING, WITH MOST OF THE DEFORMITY BEING LOCALIZED TO THE DISTAL FEMORAL METAPHYSEO-DIAPHYSEAL JUNCTION. FOUR X-RAYS ARE PROVIDED: A FULL LEG MECHANICAL AXIS FILM PA, SHOWING THE VARUS WITH SHORTENING. THE X-RAY IS UNDATED. AN AP FILM DATED (B)(6) 2011, SHOWING A MULTIPLANAR CLAMP APPLIED TO THE LEFT DISTAL FEMUR, WITH THREE SCREWS IN EACH CLAMP. THERE HAS BEEN AN OSTEOTOMY, WHICH IS IRREGULAR AND OBLIQUE, AND THERE IS 10 - 15 MM OF SEPARATION BETWEEN THE TWO ENDS. THE OSTEOTOMY IS SLIGHTLY DISTAL TO THE APEX OF THE DEFORMITY. THE PROXIMAL CLAMP HAS VERY LITTLE LENGTHENING LEFT BEFORE REACHING THE END OF THE RAIL. AP AND LATERAL FILMS DATED (B)(6) 2011, WHICH SHOW AN LRS RAIL WITH TWO STRAIGHT CLAMPS. THE LENGTHENING HAS PERHAPS SLIGHTLY INCREASED. IT IS ESSENTIAL FIRST TO LENGTHEN GRADUALLY TO STRETCH THE SOFT TISSUES. IT IS THEN POSSIBLE TO MAKE THE CORRECTION ACUTELY AFTER SHORTENING AGAIN. THE PROBLEM IN THIS SITUATION IS THAT ANGULAR CORRECTION OF VARUS FROM THE LATERAL SIDE RESULTS IN LENGTHENING, AND UNLESS THIS IS DONE FIRST, THE TISSUE TENSION WILL PROVE TO BE TOO MUCH FOR THE CLAMP. I SUSPECT THAT THE CLAMP 'BLOCKED' BECAUSE THE TENSION BECAME TOO GREAT." IN CASE FURTHER INFORMATION IS PROVIDED ON THE SPECIFIC APPLICATION OF THE SYSTEM OR ON THE PRODUCT INVOLVED, ORTHOFIX (B)(4) WILL PROMPTLY FINALIZE THE INVESTIGATION ON THE CASE. ORTHOFIX (B)(4) CONTINUES MONITORING THE PRODUCTS ON THE MARKET.

    Description of Event or Problem · 1

    THE PATIENT'S DIAGNOSIS WAS ANGULAR DEFORMITY AND SHORTENING. THE PATIENT WAS SUBMITTED TO A PROCEDURE FOR GRADUAL ANGULAR CORRECTION AND LENGTHENING ON (B)(6) 2011. INTO TREATMENT, THE DEVICE BLOCKED AND DID NOT ALLOW ANY FURTHER CORRECTION. THE PATIENT WAS SUBMITTED TO ANOTHER SURGERY, ON (B)(6) 2011, TO CHANGE THE FRAME. THE PATIENT IS CURRENTLY IN GOOD HEALTH CONDITION, ENDING TREATMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LRS MULTIPLANAR CLAMP LRS MULTIPLANAR CLAMP JDW ORTHOFIX SRL 50580 IT892933

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention NO INFORMATION HAVE BEEN MADE AVAILABLE.