MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Catalog Number 7068398 |
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 11/25/2017 |
Event Type
malfunction
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Manufacturer Narrative
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This part is not approved for use in the united states; however a like device catalog # 5440030, 510k # k102555 and (b)(4) was cleared in the united states.Product was not 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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Pre-operative diagnosis :l1 burst fracture levels :t11-l2 it was reported that during surgery, when the tightening of the set screw was done without a sequential reducer,the thread of the set screw was found to be stripped.The right l2 set screw was removed once, and checked.There was a delay of less than 60 minutes in overall procedural time.No fragments of the set screw were remaining in the patient.No patient complications were reported.
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Manufacturer Narrative
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Product analysis: set screw appears to be the screw that was misaligned and caused the splaying and thread damage.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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