Catalog Number 55840007560 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/04/2016 |
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 reported event.Image review: submitted images appear to display mas separated from the bone screw, and two driver tips sheared off at the distal tip.
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Event Description
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It was reported during surgery, the pedicle screw broke when the surgeon tried to remove it.The product came in contact with patient.Fragments of the broken screw remained in patient.Patient complications are unknown.
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Manufacturer Narrative
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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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Procedure: spondylodesis posterolateralis l5-s1, decompression at l5/s1 cum laminectomy no patient complications were reported as a result of the event.
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Manufacturer Narrative
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Product analysis: visual inspection confirms only the head assembly of the implant returned for analysis, with the (-01) bone screw component missing and not returned for analysis.The ring (-04) and crown (-03) were still assembled in the head.Microscopic examination of the (-04) ring identified ring id feature material displacement, enlarging the id, and the "ears" of the ring bent upward, thus reducing the mechanical retention of the bone screw head.The ring is noted to be fully seated in the retaining groove of the head.The above observations are consistent with mechanical overload as the mechanism of failure.
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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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