BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.0MM TI T-PLATE 5 X 7 HOLES

    MDR report key: 7172108 · Received January 8, 2018

    Report

    Report Number
    2939274-2018-50109
    Event Type
    Injury
    Date Received
    January 8, 2018
    Report Date
    December 11, 2017
    Manufacturer
    WRIGHTS LANE: SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    10887587049342
    PMA / PMN Number
    K912932
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. IT IS UNKNOWN WHEN THE EVENT OCCURRED. THIS REPORT IS FOR A T-PLATE - UNKNOWN LOT. IMPLANT DATE: UNKNOWN. EXPLANT DATE: THERE IS NO INDICATION THAT THE DEVICE WAS REMOVED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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. (B)(4)

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING ARTICLE: TSE, D: ET AL (2010) THE USE OF TITANIUM T-PLATE AS PLATFORM FOR GLOBE ALIGNMENT IN SEVERE PARALYTIC AND RESTRICTIVE STRABISMUS. AM J OPHTHALMOL, 150:404-411. (USA) THIS IS A RETROSPECTIVE STUDY TO EVALUATE LONG-TERM EFFECTIVENESS OF IMPROVED OCULAR ALIGNMENT USING A SUTURE/T-PLATE ANCHORING PLATFORM SYSTEM. THE SUTURE/T-PLATE FIXATION (SYNTHES CRANIOFACIAL 1.0-MM MODULE; SYNTHES CMF, (B)(4)) WAS USED TO CORRECT COMPLEX STRABISMUS FROM JANUARY 2003 TO DECEMBER 2007. THERE WERE 6 WOMEN AND 1 MAN WITH AN AVERAGE AGE OF 55.7 YEARS (RANGE, 24¿79 YEARS). THE TIP OF THE T-PLATE EXTENDS TO THE MEDIAL MID-ORBIT SUCH THAT THE SHAFT IS SITUATED BELOW THE FRONTOETHMOIDAL SUTURE LINE, AWAY FROM THE ANTERIOR AND POSTERIOR ETHMOIDAL ARTERIES. FOR SUTURE PLACEMENT, A FORNIX-BASED MEDIAL CONJUNCTIVAL PERITOMY IS MADE TO DELINEATE THE MEDIAL RECTUS INSERTION. SIX PATIENTS UNDERWENT BETWEEN 1 AND 3 STRABISMUS SURGERIES AND 4 PATIENTS RECEIVED BOTULINUM TOXIN TYPE A INJECTIONS TO THE ANTAGONIST MUSCLE PRIOR TO SUTURE T-PLATE PLACEMENT. ONLY 1 PATIENT DID NOT HAVE PREVIOUS STRABISMUS SURGERY OR BOTULINUM TOXIN INJECTIONS. ALL 7 PATIENTS ACHIEVED SINGLE VISION NEAR THE PRIMARY POSITION. SINGLE VISION CONSISTED OF A LIMITED FIELD OF SINGLE BINOCULAR VISION IN 4 CASES AND SINGLE MONOCULAR VISION IN 3 CASES. TWO PATIENTS DEVELOPED AN ANOMALOUS HEAD POSITION: A MILD FACE TURN IN 1 PATIENT (CASE 4) AND AN ELEVATED CHIN POSTURE ATTRIBUTABLE TO BILATERAL LIMITATION OF UPWARD GAZE FROM OCULOMOTOR NUCLEAR COMPLEX DYSFUNCTION IN ANOTHER (CASE 5). IN PATIENTS WITH T-PLATE FIXATION MEDIALLY, GLOBE RETRACTION WAS NOTED IN 3 PATIENTS ON ABDUCTION. NO POSTOPERATIVE INFECTIONS, SUTURE BREAKAGE, OR T-PLATE DISPLACEMENT WERE ENCOUNTERED. THIS IS 2 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN T-PLATE. CASE 1, (B)(6) FEMALE EXPERIENCED GLOBE RETRACTION. CASE 4, (B)(6) MALE EXPERIENCED ANOMALOUS HEAD POSITION (MILD FACE TURN). CASE 5, (B)(6) FEMALE EXPERIENCED ANOMALOUS HEAD POSITION (AN ELEVATED CHIN POSTURE). TWO UNKNOWN PATIENT¿S EXPERIENCED GLOBE RETRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16441 1.0MM TI T-PLATE 5 X 7 HOLES PLATE, FIXATION, BONE HRS WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 420.71 10887587049342

    Patients

    Seq Age Sex Outcome Treatment
    1