Patient information not available for reporting.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Hospital telephone not available for reporting.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Additional narrative: sterile part 201.932s, lot # l454937, manufacturing site: (b)(4), supplier: (b)(4).Release to warehouse: june 20, 2017.Expiry date: june 01, 2027.Non-sterile part 201.932, lot # l428783, manufacturing site: (b)(4).No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The manufacturing documents of the lot in question were reviewed and no complaint related issues were found.The raw-material testing certificates and the manufacturing papers regarding dimension, material analysis, strength and structural stability.The values were in compliance with the international standards for wrought stainless steel implants for surgery.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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