WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM TI MATRIXRIB LCKNG SCREW SELF-DRILLING/8MM - STERILE; PLATE, FIXATION, BONE
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Catalog Number 04.501.208.01S |
Device Problem
Migration (4003)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that on ma(b)(6) 2020, 5 matrixrib locking screws were noticed to have pulled off of 2 matrixrib plates.The reported screws pulled away from the bone.The issue was discovered via imaging the next day after the procedure.Initially, the reported screws were implanted on (b)(6) 2020.The surgeon decided not to revise issue.There was no patient consequence reported.Concomitant devices reported: ti matrixrib pre-contoured plate 18 holes for left ribs 8 & 9 (part # 04.501.007, lot # unknown, quantity 2); 2.7mm ti matrixrib locking screw self-drilling/8mm-sterile (part # 04.501.208.01s, lot # unknown, quantity 4).This report is for 1 2.7mm ti matrixrib locking screw self-drilling/8mm-sterile.This is report 4 of 5 for complaint (b)(4).
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