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
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
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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