It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Additional information has been requested and if received, will be provided in the supplemental report.Additional devices listed in this report: catalog description: quantity: qty: lot #: 49221010 rod to rod coupling hoffmann 3 ø5/8/11m, sel, (b)(4), j40920.49221010 rod to rod coupling hoffmann 3 ø5/8/11m, sel, (b)(4), j45818.49221020 pin to rod coupling hoffmann 3 ø4/5/6mm, sel, (b)(4), f24690.49221020 pin to rod coupling hoffmann 3 ø4/5/6mm, sel, (b)(4), j39186.49222020 5 hole pin clamp hoffmann 3 ø4/5/6mm, sel, (b)(4), r37814.49222240 5 hole pin clamp, 2 posts, 30° hoffmann , sel, (b)(4), j35081.49228150 connecting rod hoffmann 3 ø11x150mm, sel, (b)(4), 01963r.49228150 connecting rod hoffmann 3 ø11x150mm, sel, (b)(4), 03476r.49228250 connecting rod hoffmann 3 ø11x250mm, sel, (b)(4) 03946j.49228350 connecting rod hoffmann 3 ø11x350mm, sel, (b)(4) 03956j.49228400 connecting rod hoffmann 3 ø11x400mm, sel, (b)(4) 02474j.49221010 rod to rod coupling hoffmann 3 ø5/8/11m, sel, (b)(4) f24092.Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device remains implanted.
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As per literature, the heating of an external fixation frame is highly dependents on mri settings and on the structure of each frame.However, even though requested no information was provided about the mri scanner settings during this case.A picture of the built frame was provided: this frame is a complex structure with a large amount of components (including 6 pins + 21 reported parts) and includes several opened and closed loops.The frame structure is not similar to any tested frame from the operative technique.Radiologist and mr-scientists should have been consulted about this frame before performing the mri scanner.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by a deviation from operative technique recommendations.Device history files of each reported device from this frame, were reviewed: all reported devices are conforming to specifications.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.If any further information is provided, the investigation report will be updated.
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