Model Number 10-P3208-13P |
Device Problems
Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/05/2021 |
Event Type
Injury
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Manufacturer Narrative
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Patient information - unknown.Occupation - other; sales representative.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.This report is number 5 of 5 mdrs filed for the same event (reference 3005739886-2021-00028).
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Event Description
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It was reported that a procedure was performed on (b)(6) 2021, in (b)(6), utilizing the vault alif system.During the procedure two (2) of the vault alif plates did not engage onto the cage.Also, one (1) cage and plate became unstable because the connector screw came off.The doctor was able to complete the case using other vault alif cages from the set.There was no patient injury reported but there was a forty-five (45) minute delay of the procedure because of the reported issues.
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Event Description
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It was reported that a procedure was performed on (b)(6) 2021, in (b)(6), utilizing the vault alif system.During the procedure two (2) of the vault alif plates did not engage onto the cage.Also, one (1) cage and plate became unstable because the connector screw came off.The doctor was able to complete the case using other vault alif cages from the set.There was no patient injury reported but there was a forty-five (45) minute delay of the procedure because of the reported issues.
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Manufacturer Narrative
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H3 device evaluation - upon evaluation of returned product it was noted that with the complaint parts shipment were (2) additional face plates, part number 10-p3215-13p, from lot numbers 25148ps and 5862ps.These parts are not part of the complaint, and it is unknown why they were returned.Based on these findings, a medwatch report was not required for this part/lot.This report is number 5 of 5 mdrs filed for the same event (reference 3005739886-2021-00028-1.).
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Search Alerts/Recalls
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