BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE PLATE

    MDR report key: 5543659 · Received April 4, 2016

    Report

    Report Number
    2520274-2016-11914
    Event Type
    Injury
    Date Received
    April 4, 2016
    Date of Event
    December 5, 2008
    Report Date
    March 7, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN DISTRACTOR/UNKNOWN QUANTITY/UNKNOWN LOT. UDI IS UNAVAILABLE. 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 WHITE N 2008. POSTERIOR CALVARIAL VAULT EXPANSION USING DISTRACTION OSTEOGENESIS. CHILDS NERV SYST, 25:231-236. (B)(6). SIX PATIENTS UNDERWENT DISTRACTION OSTEOGENESIS OF THEIR POSTERIOR CALVARIAL DISTRACTION. DATA WAS PROSPECTIVELY COLLECTED FOR SIX PATIENTS, WHO UNDERWENT OSTEOGENESIS OF THEIR POSTERIOR CALVARIAL VAULT FOR RAISED INTRACRANIAL PRESSURE SECONDARY TO SYNDROMIC MULTISUTURE CRANIOSYNOSTOSIS BETWEEN (B)(6) 2006 AND (B)(6) 2007. THE MEAN AGE AT TIME OF SURGERY WAS 1 YEAR 3 MONTHS. THE MEAN PERIOD OF DISTRACTION WAS 28 DAYS. DATA WAS COLLECTED FOR THE LENGTH OF THE DISTRACTION PERIOD, THE LENGTH OF THE CONSOLIDATION PERIOD AND THE DISTANCE OF THE ADVANCEMENT ACHIEVED. THREE INTERNAL 30 MM TITANIUM SINGLE VECTOR DISTRACTORS (SYNTHES, (B)(4), USA) WERE USED IN FOR EACH CASE. THERE WERE TWO LATERAL DISTRACTORS WERE POSITIONED IN EACH TEMPORAL REGION AND A SUPERIOR ONE PLACED OFF CENTER TO AVOID THE SAGITTAL SINUS. THIS REPORT IS FOR AN UNKNOWN DISTRACTOR AND REFERS TO THE FOLLOWING; CASE 4 - (B)(6) MALE EXPERIENCED DURING THE DISTRACTION PERIOD OF 31 DAYS, THERE WAS A LOOSENING OF A FOOTPLATE. FOOTPLATE WAS REPOSITIONED UNDER ANESTHESIA. THIS IS REPORT 4 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200609 BONE PLATE JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 MO Required Intervention