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 06/10/2016 |
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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Levels: l2/4 it was reported that patient was diagnosed with l3 burst fracture and underwent a surgery.During the surgery, extender body was unable to be disengaged from screws after final tightening.A surgeon removed them barely from the screws.The extender body showed ¿rd¿ instead of ¿ej¿ in the extender window.The product came in contact with the patient.There was a delay of less than 60 minutes in the overall procedure due to the event.No patient complications were reported.
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Manufacturer Narrative
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Product analysis: functional bench evaluation of the instrument did not identify significant issues with opening, closing, or releasing a sample mas head from the instrument retention features.During in vivo usage, surrounding biological material or technique could potentially exert external forces on the instrument, and increase the force required to remove the instrument.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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Search Alerts/Recalls
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