Catalog Number PIP-200-20P-WW |
Device Problems
Break (1069); Fracture (1260)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Event Description
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It was reported the surgeon was impacting the implant with minimal force and the implant broke.A second implant was taken out of the box and the same thing happened.Surgeon then had to go to a bigger size because we had no other 20ps available which added on another 1.5 hours to the case.The surgeon is a new, 1st time user of the product.It was reported the patient was not injured.
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Manufacturer Narrative
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Integra has completed their internal investigation on 23 oct 2015.The investigation activities included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: device history record reviewed.The review did not identify a nonconformance related to the complaint.A review of complaints for pip implant fractures (both intra-op and post-op) during the last 5 years showed 61 complaints.During this period of time there have been (b)(4) units sold.The resulting rate of complaints is (b)(4) which does not represent an adverse trend.Conclusion: the cause of the failure has been identified as resulting from impacting the unsupported head when the stem of the implant has not been fully inserted into the medullar canal due to an improperly prepared oblique osteotomy.
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Search Alerts/Recalls
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