Model Number 101-9816 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problems
Fall (1848); Therapeutic Effects, Unexpected (2099); No Code Available (3191)
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Event Date 12/08/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Additional suspect medical device component involved in the event: product family: superion implant, upn: 101-9814, model: 101-9814, serial: n/a, batch: 800256.
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Event Description
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It was reported that patient had a fall after lifting something heavy.The patient then experienced loss of efficacy.X-rays showed that the implant at l3/4 had a bent upper left cam lobe and that the implant at l4/5 had dislodged from the interspinous space.The patient underwent a revision procedure where the implant at l3/4 was removed and replaced with a new implant and the implant at l4/5 was removed.The patient was doing well post operatively.
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Event Description
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It was reported that patient had a fall after lifting something heavy.The patient then experienced loss of efficacy.X-rays showed that the implant at l3/4 had a bent upper left cam lobe and that the implant at l4/5 had dislodged from the interspinous space.The patient underwent a revision procedure where the implant at l3/4 was removed and replaced with a new implant and the implant at l4/5 was removed.The patient was doing well post operatively.
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Manufacturer Narrative
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The returned devices were analyzed and found; superion implant, lot number 800130.The cam-lobes were significantly bent.The damaged cam lobes suggest that the user likely exerted excessive force while attempting to deploy the implant against a rigid obstruction (spinous process) during the implant procedure.The complaint of the superion implant having a bent cam lobe was confirmed through product analysis.The probable cause has been traced to unintended use error caused or contributed to event.Superion implant, lot number 800256.The implant exhibits normal characteristics.The complaint of the implant became dislodged after patient fell could not be confirmed with testing of the product return as no problem has been detected.
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Search Alerts/Recalls
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