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 Problems
Break (1069); Difficult to Remove (1528)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/21/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the r eported event.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 a percutaneous pedicle screw procedure.During procedure, the extender could not be removed at all after break-off at l3/4.Finally, a cobb was used for removing it.Tip of the extender broke and was removed.The product came in contact with the patient.No patient complications were reported.
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Manufacturer Narrative
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Product analysis: complaint is of a functional nature.The instrument in question has been damaged as received, preventing evaluation of function.The instrument has been received in a manner unsuitable for evaluation.
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Search Alerts/Recalls
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