WARSAW ORTHOPEDICS CD HORIZON SOLERA SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Catalog Number 641003080 |
Device Problem
Metal Shedding Debris (1804)
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Patient Problem
Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.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 on an unknown date, post-op, patient presented to surgeon with pain.Bone scan completed and showed hot spots at l3 and s1.During removal surgeon noticed a large amount of metallosis on the left l3 level.
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Manufacturer Narrative
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Product analysis: the rod has witness marks indicating that it was moving within the set screw and the saddle of the bone screw.The witness marks are located on the very end of the rod.The root cause of the one set screw backing out is consistent with angle of the rod in respect to the saddle of the bone screw.This allowed the rod to move inside the bone screw head, removing material from the set screw.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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