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 07/07/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 7578302, lot no: em15l033, qty: 8; product id: 7578302, lot no: em15h050, qty: 4.The product is not returned to manufacturer for evaluation therefore cause of event cannot be determined.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 peri operative, extender was not removable from the screws.It was not possible to pull the extender into the eject position.No patient's complications were reported.
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Manufacturer Narrative
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Product analysis: all 12 extenders were evaluated and all of them have same results which is as follows: 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 from the mas head.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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