Patient initials are (b)(6).Patient weight is unknown.Additional product codes for this report include mni, mnh, kwp, and kwq.(b)(4) lot unknown.Date of original implant procedure is unknown.Per facility, the complainant parts were returned to the patient and are not available for manufacturer evaluation.(b)(4).Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.Device 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.
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It was reported that a patient underwent a posterior spinal fusion procedure from t10-l3 with synthes universal spine system (uss) instrumentation on an unknown date.Thereafter, the patient achieved a solid fusion at the t10-l3 level with no hardware related issues.At an unknown time, however, the patient developed junctional kyphosis above the level of fusion (t10 level) and stenosis below the level of fusion at the l5 level.Pain, irritation, and discomfort were also noted.As a result, the patient was returned to the operating room for revision on (b)(6) 2015.During the revision, the rods were removed and the purchase of all screws was checked.Eight (8) of the twelve (12) screws between t10 and l3 were removed and replaced with larger diameter uss screws.Also, new bilateral screws were placed at t7, t8, t9, l4, s1, and ilium.A decompression was performed at l4-l5 and new rods were contoured then connected from t7-ilium.The procedure was successfully completed.This report is 4 of 10 for (b)(4).
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