MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Catalog Number 7578302 |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/12/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluation anticipated, but not yet begun.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the patient underwent percutaneous stabilization of l1 due to t12 vertebral compression fracture possible osteoporosis.During surgery, after screws were inserted and rods were reduced and set screws broken off, when it came to remove the extenders, 3 of 4 refused to move to eject.Excessive force had to be used to lift tab enough to release extended.All extenders were moved to "ld" and "ej" prior to being handed over in case to eliminate this problem.Apart from this the surgery was completed as per surgical technique by an experienced surgeon.Surgery took slightly longer than planned, causing surgeon more concerned regarding future use of extenders.Products came in contact with the patient.No patient complications were reported.
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Manufacturer Narrative
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Product analysis: manual evaluation of returned instruments confirmed significant force required to engage ¿ej¿ eject mode function.Re-assembly of instrument identified noticeable improvement in force required to engage ¿ej¿ eject mode function.Dimensional examination of multiple components of one of the instruments identified dimensions outside of print specifications.The above observations are consistent with manufacturing error.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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