Zimmer biomet complaint number: (b)(4).One certain® bellatek® encode® healing abutment was returned for inspection.Visual inspection revealed wear about the collar and the threads.The hex head was also slightly worn, but functional.The bottom hex contained additional debris.The implant that allegedly would not mate was not returned for inspection.The returned device was examined visually by the naked eye and through magnification.The product was functionally tested with an in house mating implant, and found to assemble and seat as normal.The complaint remains unconfirmed.A device history review was performed and no related nonconformance¿s were noted.Also, a complaint history search was performed using our complaint handling system and there were no additional related complaints for this product lot.Appropriate documentation was reviewed and the following information was identified: product catalog for restorative technologies¿ instres rev 04/16.Warnings: ¿mishandling of small components inside the patient¿s mouth carries a risk of aspiration and/or swallowing.Fracture of a restoration may occur when an abutment is loaded beyond its functional capability.Reuse of biomet 3i products that are labeled for single-use may result in product contamination, patient infection and/or failure of the device to perform as intended.The alleged complaint is unconfirmed and a root cause cannot be determined.
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