Model Number 10-P3208-13P |
Device Problems
Use of Device Problem (1670); Positioning Problem (3009)
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Patient Problem
Insufficient Information (4580)
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Event Date 08/29/2022 |
Event Type
Injury
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Event Description
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It was reported that a procedure was performed on (b)(6) 2022, utilizing the vault alif system.The plate and cage were assembled on the back table.The set screw was torqued to assemble the plate and cage components.The assembly was then inserted into the disc space with four screws.Upon attempting to assemble the lock screw it was noted that it did not seem to fit as usual.An x-ray was then taken and it was noted the vault alif peek plate 32mm x 13mm 8 deg lordosis (10-p3208-13p) appeared to be skewed from the vault alif peek cage 32mm x 13mm 8 deg lordosis (10-c3208-13).The screws and plate/cage assembly were removed and replaced with others of the same size with no further issue.
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Manufacturer Narrative
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Occupation - other; sales representative.Other - evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.This report is number 1 of 3 mdrs filed for the same event (reference 3005739886-2022-00030 / 00032).
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Event Description
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It was reported that a procedure was performed on (b)(6) 2022, utilizing the vault alif system.The plate and cage were assembled on the back table.The set screw was torqued to assemble the plate and cage components.The assembly was then inserted into the disc space with four screws.Upon attempting to assemble the lock screw it was noted that it did not seem to fit as usual.An x-ray was then taken and it was noted the vault alif peek plate 32mm x 13mm 8 deg lordosis (10-p3208-13p) appeared to be skewed from the vault alif peek cage 32mm x 13mm 8 deg lordosis (10-c3208-13).The screws and plate/cage assembly were removed and replaced with others of the same size with no further issue.
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Manufacturer Narrative
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H3 device evaluation - the threads of all items returned were shown to be in good functional condition.The sleeve was removed from 10-p3208-13p to check for any abnormalities that would not be visible in the assembled state.No abnormalities were observed.The peek around the sleeve was cut, possibly with a midas burr.Along with cuts to the peek, the pin which retains the sleeve was damaged, making removal of the sleeve easy.Also, 3 of the 4 bone screw holes in the plate have cuts that appear to have been made by the threads of the bone screws.The bone screws were not returned for this investigation.As the complaint centers around a condition observed inter-operatively, being the plate and cage were skewed from one another, confirmation of the complaint cannot be achieved do to the lack of the inter-operative x-ray that was used to determine necessity to remove the cage.Also, the returned implants do not assist in complaint confirmation due to the damage noted.The complaint was unsubstantiated.Review of device history records (39459_10-p3208-13p) found twenty-five (25) pieces of this lot released for distribution on 4/6/2022 with no deviation or anomalies.Two-year complaint history review found this to be the only complaint of this nature for any of the plate/cage part numbers in the vault alif family.This report is number 1 of 3 mdrs filed for the same event (reference 3005739886-2022-00030-1 / 00032-1).
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Search Alerts/Recalls
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