Prima Implant System 15433KRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI D76815433K0), received between Mar 21, 2023 and Mar 21, 2023 — classified as 1 injury.

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

2 other recalls cover devices cleared under the same FDA submission (K050506, K072768); they may or may not involve this specific model.

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 21, 2023Failure to Osseointegrate; Failure to Osseointegrate

  FAILED TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16586598 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050506, K072768. One submission often covers many models, so check the product and lot details in each record.

• Z-1179-2018 · Oct 16, 2017 · Terminated
  STAGE-1 RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K
• Z-0727-2018 · Aug 25, 2017 · Terminated
  Stage-1 RDS Indexed Abutment for RDS Stage-1 Single Stage Implants Keystone s implants are intended for use in partially or fully edentulous mandibles and maxillae, in support