BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHES

    MDR report key: 1275283 · Received December 22, 2008

    Report

    Report Number
    1275283
    Event Type
    Injury
    Date Received
    December 22, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 26, 2008
    Manufacturer
    SYNTHES INC.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A FEMALE UNDERWENT L POSTERIOR TIBIAL TENDON REPAIR, FLEXOR DIGITORUM LONGUS TENDON TRANSFER, ANTERIOR AND POSTERIOR CALCANEAL OSTEOTOMIES, 1ST METATARSAL TARSAL FUSION, MODIFIED MCBRIDE, AKIN OSTEOTOMY GREAT TOE, ACHILLES LENGTHENING, ICBG ASPIRATE, MTF TRICORITCAL BONE WEDGE ALLOGRAFT, SPRING LIGAMENT REPAIR IN 2007. FIXATION OF THE ANTERIOR OSTEOTOMY WAS ACHIEVED WITH 2.7 X 50 AND 2.4 X 40 MM SCREWS; EXCELLENT FIT OF THE GRAFT WAS OBTAINED. POSTOPERATIVE INSTRUCTIONS INCLUDED SHORT-LEG NON-WEIGHT-BEARING CAST X 6 WKS; SHE THEN BEGAN PARTIAL WEIGHT BEARING AT 6 WKS POSTOP AND FULL WEIGHT BEARING AT 8 WKS (WEARING REMOVABLE BOOT). SHE BEGAN PHYSICAL THERAPY AT 9 WKS. XRAYS IN 2008, NOTED GOOD ALIGNMENT AND SHOWED HEALING OF THE FUSION, GRAFT AND CALCANEAL OSTEOTOMY. AS OF 2008, SOME SENSITIVITY STILL REMAINED OVER THE LATERAL COLUMN LENGTHENING SITE; X-RAYS SHOWED GOOD ALIGNMENT. THE NEXT X-RAYS, TAKEN THREE MONTHS, SHOWED THE DORSAL SCREW AT THE LATERAL COLUMN LENGTHENING SITE BROKEN; CT SCAN NOTED SCLEROTIC CHANGE AT MARGINS OF THE ANTERIOR CALCANEAL OSTEOTOMY AND PERSISTENT LUCENCY. THE PT REPORTED PAIN AND NUMBNESS OF THE LATERAL PART OF THE FOOT. THREE MONTHS LATER, THE PT UNDERWENT REMOVAL OF THE PAINFUL SCREW (2.7 MM). THE OTHER SCREW (2.4) WAS ALSO REMOVED BECAUSE IT WAS NOTED LOOSE AND POSSIBLY IMPINGING AT THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES SCREW, CORTEX SELF-TAPPING HWC SYNTHES INC. 2.7 MM, 50 MM *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R