Model Number 101-9812 |
Device Problem
Malposition of Device (2616)
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Patient Problems
Pain (1994); No Code Available (3191)
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Event Date 10/14/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the patient was experiencing back and leg pain when standing.It was assess that the implanted spacer was not sitting flush to the spinolaminar junction.Patient then underwent a revision procedure to replace the spacer and is doing well post-operatively.
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Manufacturer Narrative
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H6 patient code 3191: no code available was used because there is not an equivalent fda code for surgical intervention.Visual examination of the returned 101-series 12mm implant lot number 800235 revealed that the right wing of the superior cam-lobe was minutely bent towards the median line.The implant functioned acceptably upon functional testing and the damage to implant indicates failure was likely due to forced deployment against a rigid obstruction such as the spinous process.The complaint of malposition of the device was confirmed through device analysis.The probable cause was traced to unintended use error caused or contributed to the event.
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Event Description
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It was reported that the patient was experiencing back and leg pain when standing.It was assessed that the implanted spacer was not sitting flush to the spinolaminar junction.Patient then underwent a revision procedure to replace the spacer and is doing well post-operatively.
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Search Alerts/Recalls
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