AXIOM IMPLANT ?4.0 x 12.0

Description of Event or Problem

The clinician reports the implant was inserted (B)(6) 2026 in FDI 46. On (B)(6) 2026 non-osseointegration was verified. The device was forwarded to the manufacturer. There were no reported patient injuries or complications.

Additional Manufacturer Narrative

The batch number could be verified. Our manufacturing Q-system assures,that production and process controls are in place to ensure that batchesconfirm to the applicable specifications before they are distributed.?The non-integration of an endosseous dental implant during the healingphase is a known inherent risk of the treatment with dental implants.Most implant failures occur before occlusal loading (Analainen et al.2009). Based on clinical studies about 1-3% of the implants fail withinthe first year after implantation (Ganeles et al. 2008).Implants may have to be removed in case one or more of the implantsuccess criteria are not met.Implant success criteria according to Buser et al. (1991) are:1. Absence of persistent subjective complaints such as pain, foreignbody sensation and /or dysesthesia.2. Absence of a recurrent peri-implant infection with suppuration.3. Absence of implant mobility.4. Absence of a continuous radiolucency around the implant.The manufacturer's trend analysis confirms that the reported earlyfailure rate associated with its dental implants is below the expectedfailure rate for this treatment as published in the scientificliterature.