Zimmerbiomet complaint number: (b)(4).The certain gold-tite hexed screw (iunihg) was not returned.Therefore, a visual and functional inspection of the product could not be performed.No photographs or radiographs of the screw were available for assessment.No device lot number was provided so a device history record review and a complaint history review could not be performed.Appropriate documentation was reviewed and the following information was identified: review of biomet 3i restorative ifu (p-iis086gr rev.E 11/2015) and biomet 3i restorative manual (instrm rev b 10/15) identified information regarding screw loosening under section title warnings and precautions.As per the applicable ifu, improper technique can lead to implant restoration fracture and screw loosening.Surgical manual highlights the torque recommendation under torque matrix ¿ internal connection.Also, patient factors like presence of occlusal abnormalities or parafunctional habits (e.G.Severe bruxism, clenching, overloading or gnawing) may cause screw loosening, restoration fracture, and/or implant failure.Complainant reported that the abutment loosened and he retightened the screw.The reported event (screw loosening) could not be verified as screw was not returned for inspection and the exact details and conditions of the device usage could not be replicated.A root cause for this complaint could not be determined.
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