XiVE® 32262453 (REF 26-2453)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI EFRI322624532), received between Mar 8, 2016 and Mar 8, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 8, 2016Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT A XIVE S PLUS IMPLANT WAS INSERTED IN THE JAW OF A PATIENT. THE PATIENT HAD POSTOPERATIVE PAIN FOR SEVERAL DAYS, EVEN THOUGH ANTIBIOTICS AND PAINKILLERS WERE BEING TAKEN. A DVT WAS MADE AFTER IMPLANTATION AND THERE WAS NO CONTACT OF THE IMPLANT TO SURROUNDING NERVE STRUCTURES. THE IMPLANT WAS PLACED COMPLETELY INTRAOSSEOUS. THE DIAGNOSTIC FINDINGS BEFORE EXPLANTATION ARE DESCRIBED AS "INFECTION" AND "PERIIMPLANTITIS". THE CLINICIAN EXPRESSED THE SUSPICION THAT THERE MAY BE AN ALLERGY TO TITANIUM BECAUSE THE PATIENT HAD NO MORE PAIN AFTER REMOVAL OF THE IMPLANT APPROXIMATELY TWO WEEKS LATER.

  Patient problems: Failure of Implant; Hypersensitivity/Allergic reaction; Pain

  MAUDE report 5486303 ↗