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Tapered SwissPlus® SPMB10Recalls & reported problems

ZimVie US Corp LLC · Class 2 · Implant

All models of Tapered SwissPlus (12)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
18
Deaths reported
0
Injuries reported
18
Recalls naming it
0

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00889024017467), received between Mar 17, 2020 and Dec 4, 2025 — classified as 18 injuries.

The most frequently reported specific device problem is “Fracture” (3 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.

Reports received per month

Nov 2023: 2 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 2 reportsDec 2025: 2 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem15
  • Fracture3

Patient problems

  • Osteolysis11
  • Unspecified Infection11
  • Inflammation6
  • Pain4
  • Abscess2
  • No Clinical Signs, Symptoms or Conditions2
  • Failure of Implant1
  • No Code Available1

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 4, 2025Fracture; Fracture

    THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER #15 FAILED BECAUSE IT FRACTURED AT THE HEAD. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. PAIN WAS REPORTED AS A RESULT OF THE EVENT.

    Patient problems: Pain

    MAUDE report 23713986 ↗
  • InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE # 45 WAS REMOVED DUE TO A PERI-IMPLANTITIS AND THE LOSS OF THE ASSOCIATED CROWN. AFTER FOLLOW UP WITH THE DOCTOR, IT WAS CONFIRMED THAT ABUTMENT (CROWN) DOES NOT HAVE AN ISSUE. IT IS JUST A CONCOMITANT PRODUCT.

    Patient problems: Osteolysis; Unspecified Infection

    MAUDE report 23702637 ↗
  • InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #34 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN, ABSCESS AND EDEMA.

    Patient problems: Inflammation; Osteolysis; Unspecified Infection

    MAUDE report 23479956 ↗
  • InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO PERI-IMPLANTITIS.

    Patient problems: Osteolysis; Unspecified Infection

    MAUDE report 23478966 ↗
  • InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    DOCTOR REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. PATIENT REFERRED PAIN. PATIENT HAS BEEN RESCHEDULED FOR NEW IMPLANT PLACEMENT IN 3 MONTHS.

    Patient problems: Pain; Unspecified Infection

    MAUDE report 22121551 ↗
  • InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 46 WAS REMOVED DUE TO PERI-IMPLANTITIS.

    Patient problems: Osteolysis; Unspecified Infection

    MAUDE report 21952028 ↗
  • InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH #14 WAS REMOVED DUE TO PERI-IMPLANTITIS.

    Patient problems: Osteolysis; Unspecified Infection

    MAUDE report 19557797 ↗
  • InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #24 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. THE DOCTOR REPORTED INFLAMMATION + EDEMA.

    Patient problems: Inflammation; Osteolysis; Unspecified Infection

    MAUDE report 18132670 ↗
  • InjuryNov 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #23 WAS REMOVED DUE TO PERIIMPLANTITIS.

    Patient problems: Osteolysis; Unspecified Infection

    MAUDE report 18063936 ↗
  • InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH 4 WERE REMOVED DUE TO PERI-IMPLANTITIS. ABSCESS AND INFLAMMATION WERE REPORTED AS A RESULT OF THE EVENT.

    Patient problems: Abscess; Inflammation; Osteolysis; Unspecified Infection

    MAUDE report 17087126 ↗
  • InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH #5 WAS REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION AND ABSCESS WERE REPORTED AS A RESULT OF THE EVENT.

    Patient problems: Abscess; Inflammation; Osteolysis; Unspecified Infection

    MAUDE report 17086914 ↗
  • InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    DOCTOR REPORTED BONE LOSS AFTER PRIMARY STABILITY AT TOOTH SITE 23.

    Patient problems: Osteolysis

    MAUDE report 16830820 ↗
  • InjuryJun 22, 2022Fracture; Fracture

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BECOMING FRACTURED AT THE SITE.

    Patient problems: Failure of Implant

    MAUDE report 14780576 ↗
  • InjuryJun 10, 2022Fracture; Fracture

    IT WAS REPORTED THAT IMPLANT FRACTURED AND WAS REMOVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14652478 ↗
  • InjuryDec 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THE IMPLANT AT TOOTH SITE # 5 WAS REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.

    Patient problems: Inflammation; Osteolysis; Unspecified Infection

    MAUDE report 13026769 ↗
  • InjuryAug 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THE IMPLANT AT TOOTH SITE # 22 LACKED PRIMARY STABILITY, AND WAS REMOVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12331951 ↗
  • 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 SURGERY AND WAS REMOVED. NO OTHER IMPLANT WAS PLACED IN THE SAME SURGERY. AS A CONSEQUENCE OF THE EVENT PATIENT FELT PAIN AND SITE PRESENTED INFLAMMATION.

    Patient problems: Inflammation; Pain

    MAUDE report 11410567 ↗
  • InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

    Patient problems: No Code Available; Pain

    MAUDE report 9841152 ↗

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Sources and updates

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