Tapered SwissPlus® SPMB12Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024017474), received between Mar 4, 2021 and Mar 18, 2024 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2024Separation Failure; Separation Failure

  IT WAS REPORTED THAT WHEN THE DOCTOR PLACED THE IMPLANT AND WANTED TO REMOVE THE MOUNT TO CONTINUE WITH THE TRANSFER, THE MOUNT WAS STUCK AND THE DOCTOR HAD TO REMOVE THE IMPLANT. TOOTH SITE 22. PROCEDURE WAS NOT COMPLETED WITH OTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18925351 ↗
• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH #14 AND 23 WERE REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 16923719 ↗
• MalfunctionDec 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE DENTAL SURGICAL PROCEDURE HE REALIZED THAT WITHIN THE STERILE PACKAGING, THE IMPLANT WAS NOT TIGHT TO THE MOUNTING DEVICE. THE IMPLANT WAS LOOSE. THE DOCTOR CONFIRMS THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12923457 ↗
• MalfunctionApr 1, 2021Fracture; Fracture

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11601106 ↗
• MalfunctionApr 1, 2021Fracture; Fracture

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11601088 ↗
• InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANT IN LACK OF PRIMARY STABILITY AND WAS REMOVED. NO OTHER IMPLANT WAS PLACED IN THE SAME SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11434398 ↗
• InjuryMar 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT DID NOT ACHIEVE PRIMARY STABILITY DURING SURGERY AND WAS REMOVED. NO OTHER IMPLANT WAS PLACED IN THE SAME SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11419771 ↗
• InjuryMar 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT DID NOT ACHIEVE PRIMARY STABILITY DURING PLACEMENT PROCEDURE AND WAS REMOVED. NO OTHER IMPLANT WAS PLACED IN THE SAME PROCEDURE. PAIN AND BONE LOSS WERE REPORTED AS A CONSEQUENCE OF THE EVENT.

  Patient problems: Osteolysis; Pain

  MAUDE report 11419603 ↗
• InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANT DID NOT ACHIEVE PRIMARY STABILITY DURING PLACEMENT AND WAS REMOVED. NO OTHER IMPLANT WAS PLACED IN THE SAME SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11410389 ↗