No product was returned for inspection.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: instructions for use for zimmer dental implant systems¿ 4894i rev 3-07/09.Zimmer dental abutments are seated with the 1.25mm standard hex tool, latchlock hex tool, or the spectra-cone seating tool.The use of a prosthetic torque wrench is recommended to ensure optimum torque when placing the abutment or abutment screw.When using the latchlock hex tool, operate at 25rpm or less with a maximum torque of 30ncm.Risks associated with the reported event are highlighted in the risk management files rm-002z6 rev 2 and rm-002b7 rev 4: excessive loading on abutment/implant assembly, leading to abutment and/or screw failure.Screw over-torqued into implant, causing abutment and/or screw failure.Incorrect assembly of the abutment and/or screw to the implant (i.E.Crossthreading, abutment not seated properly, improper torque application, used with incorrect implant), causing abutment and/or screw fracture and implant failure.Without the returned product, there is not enough evidence to form a conclusion on the reported event of abutment screw fracture.Therefore, the complaint is non-verifiable.A probable cause cannot be determined.
|