Model Number AE-QAS-SP42 |
Device Problem
Osseointegration Problem (3003)
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Patient Problem
Failure of Implant (1924)
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Event Date 08/02/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
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Event Description
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Iit was reported that there was an issue with (b)(4) collect.No.Qas spine anterior stabilis.According to the complaint description, there was an issue with activl implant post surgery.The original procedure was a lumbar total disc arthroplasty of l5-s1 in (b)(6) 2020.The patient is still having occasional neuropathy and mild low back pain.There was a temporary impairment.The patient had repeat imaging studies due to the pain; initially the implant positioning was good and other surrounding structures were normal.The patient did not experience trauma or fall.On (b)(6), results of computed tomography (ct) myelogram showed interval development of bilateral l5 pars defects and right l5 laminar fracture, without spondylolithesis.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00579 (400523620 - ae-qas-sp42), 9610612-2021-00576 (400523468 - ae-qas-sp42).
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Event Description
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Associated medwatch-reports: 9610612-2021-00579 ((b)(6) - ae-qas-sp42), 9610612-2021-00580 ((b)(6) - ae-qas-sp42), and 9610612-2021-00576 ((b)(6) - ae-qas-sp42).
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Manufacturer Narrative
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Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that neither an article number nor a lot number was provided, a review of the device history records must remain incomplete.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.
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Search Alerts/Recalls
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