Model Number 1192 |
Device Problem
Fracture (1260)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/11/2018 |
Event Type
Injury
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Manufacturer Narrative
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The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.
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Event Description
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This report is related to a (b)(6) patient.It was reported the patient's anchor was found to be broken during a surgical procedure (reported under mfr.Report#: 1627487-2018-11573).In turn, the anchor was explanted and replaced.Surgical intervention addressed the patient's issue.
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Manufacturer Narrative
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Corrected data: information related to concomitant medical products and therapy date was inadvertently omitted from the initial report; (device evaluated by manufacturer) was answered incorrectly on the initial report.Concomitant medical products and therapy dates: model: 3660, scs ipg, implant/therapy date: unknown.
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Search Alerts/Recalls
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