MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL
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Catalog Number 5440030 |
Device Problem
Metal Shedding Debris (1804)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/21/2016 |
Event Type
malfunction
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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.
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Event Description
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It was reported that on an unknown date in 2012, the patient underwent a spinal fusion surgery at l3-5, with the help of pedicle screws.Post-operatively, due to degenerative disc disease and central stenosis, patient underwent revision surgery (posterior spinal fusion), extending fusion from l2 to l5.During this surgery, while implanting set screw at right-side l5 level, the surgeon experienced shearing.Three different set screws sheared off metal fragments when surgeon was trying to place them during provisional tightening.A final set screw was used successfully after the surgeon backed out the pedicle screw a bit.Metal shards from the set screws were visible inside the patients wound and had to be evacuated by the surgeon and his assistant.Reportedly, the problem was caused as the interface between the 4.75 pedicle screw head and the set screw was causing the metal fragments to shear off of the set screw.The pedicle screw remained implanted in the patient.There were no patient complications reported.
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Manufacturer Narrative
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Product analysis: visual and optical examination of the top flank of the initial thread identified deformation and thread shearing, consistent with significant pre-load prior to final tightening.The above observations are consistent incomplete seating of the rod in the bone screw saddle prior to tightening of the set screw.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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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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