Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Unspecified Infection (1930); No Information (3190); No Code Available (3191)
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Event Date 10/11/2013 |
Event Type
Injury
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Manufacturer Narrative
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Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Report four of four for the same event; see also 3004485144-2016-00007 through 00009.
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Event Description
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Legal counsel for patient reported that patient had initial spinal surgery with biomet products.Patient's legal counsel further reports corrective surgery was performed.No further allegations received at this time.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.
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Manufacturer Narrative
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Reference reports 3004485144-2016-00007 thru 3004485144-2016-00010, 3012447612-2017-00154 thru 3012447612-2017-00157, and voluntary report mw5068372.
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Event Description
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It was reported that a revision surgery was performed to address pseudoarthrosis at levels t12-l1 and l2-l3.Information from voluntary medwatch mw5068372 states that the revision also addressed cap screws which were not tight, followed by screws which were loose, followed by broken rod, and an infection.This is report four of eight for this event.
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Search Alerts/Recalls
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