Model Number 26-PA-35-14 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Muscle Weakness (1967); Loss of Range of Motion (2032); Multiple Fractures (4519)
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Event Date 02/01/2022 |
Event Type
Injury
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Event Description
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Our distribution partner surgalign reported that "patient developed bilateral t1 pedicle fractures resulting in bilateral hand weakness.
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Manufacturer Narrative
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The device remains in patient and is not available for investigation.A dhr review has not been conducted or confirmed that device(s) met specification prior to shipping.This report will be updated should this information become available at a later date.
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Manufacturer Narrative
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The device remains in patient and is not availabe for investigation.A dhr review has not been conducted or confirmed that device(s) met specification prior to shipping.This report will be updated should this information become available at a later date.The following sections of this report have been left blank due to the information being unavailable or unapplicable at this time:.
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Event Description
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Our distribution partner surgalign reported that "patient developed bilateral t1 pedicle fractures resulting in bilateral hand weakness.
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Search Alerts/Recalls
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