Tapered SwissPlus® SPB8Recalls & 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
Quick summary
This ZimVie SwissPlus dental implant is placed in the jaw to hold replacement teeth. Reports mostly describe infection around the implant with bone loss, pain and inflammation, often mentioning removal of the implant. There are 42 reports naming its identifier, including 38 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 40
- Deaths reported
- 0
- Injuries reported
- 36
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00889024017207), received between Nov 26, 2019 and May 8, 2026 — classified as 36 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Separation Failure” (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 Problem35
- Separation Failure3
- Component Missing1
- Fracture1
- Loss of Osseointegration1
Patient problems
- Unspecified Infection29
- Osteolysis23
- Pain14
- Inflammation6
- No Clinical Signs, Symptoms or Conditions4
- Sinus Perforation2
- Discomfort1
- Edema1
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
InjuryMay 8, 2026Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A LOSS OF INTEGRATION DUE TO A PERI-IMPLANTITIS. IMPLANT WAS REMOVED. PATIENT WILL RETURN TO COMPLETE THE PROCEDURE. BONE TYPE: II.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25120963 ↗InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #33 AND #43 WERE REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED BY PLACING OTHER IMPLANTS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24498073 ↗InjuryDec 20, 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 #35 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 23858501 ↗MalfunctionDec 4, 2025Separation Failure; Separation Failure
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Inflammation; Pain
MAUDE report 23715147 ↗InjuryNov 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN IMPLANT WAS REMOVED DUE TO BONE LOSS AT TOOTH SITE # 46.
Patient problems: Osteolysis
MAUDE report 23625133 ↗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 #47 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23480408 ↗InjuryOct 27, 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 #26 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 23393914 ↗InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT ON TOOTH LOCATION 35 WAS REMOVED DUE TO PERI-IMPLANTITIS.PAIN, INFLAMMATION AND ABCESS REPORTED AS A CONSEQUENCE OF THE EVENT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 21751047 ↗InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOT SITE 36 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21699169 ↗InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED PERI IMPLANTITIS AT TOOTH SITE #46 FOUR MONTHS AFTER IMPLANT PLACEMENT, AND THE IMPLANT WAS REMOVED. INFLAMMATION AND ABSCESS WERE REPORTED AS A RESULT OF THE EVENT .
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 21629004 ↗InjuryJan 9, 2025Fracture; Fracture
IT WAS REPORTED A FRACTURE OF THE UPPER PART OF THE IMPLANT AT TOOTH SITE 15 OBSERVED WHEN THE CLINICAL PROCEDURE WAS FINISHED AND PATIENT CAME TO THE CLINIC WITH THE IMPLANT FRACTURED. THE PROCESS WAS COMPLETED WITH ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21110543 ↗MalfunctionOct 30, 2024Separation Failure; Separation Failure
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20566384 ↗InjuryOct 29, 2024Adverse 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: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 20562187 ↗InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITE #13-#21. IMPLANTS WERE REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20368358 ↗InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH #47 WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN AND ABSCESS WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 19741034 ↗InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IMPLANT PLACEMENT IN 2021, PROSTHETIC LOADING AND CROWN IN (B)(6) 2022. PAIN DURING DENTAL WHITENING. IMPLANT #46 REMOVED. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT. PROCEDURE NOT COMPLETED.
Patient problems: Inflammation; Pain
MAUDE report 19688315 ↗InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REMOVAL OF IMPLANT #16 DUE TO TOTAL LOSS OF INTEGRATION AFTER PERIIMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19508168 ↗MalfunctionApr 22, 2024Component Missing; Component Missing
DOCTOR HAS RECEIVED AN EMPTY PACKAGE, WITHOUT THE IMPLANT. PROCEDURE COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19152271 ↗MalfunctionApr 12, 2024Separation Failure; Separation Failure
IT WAS REPORTED THAT THE MOUNT WAS SO STIFF THAT THE DOCTOR COULD NOT REMOVE IT. THEREFORE, THE IMPLANT AT TOOTH LOCATION #28 WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19100157 ↗InjuryJan 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER #14 & #15 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. BONE TYPE: IV.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 18578930 ↗InjuryJan 12, 2024Adverse 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: Necrosis; Pain
MAUDE report 18505108 ↗InjuryDec 5, 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 #26 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 18265317 ↗InjuryNov 16, 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 POSITION #16 FAILED DUE TO A SINUS PERFORATION. THE PROCEDURE WAS NOT COMPLETED WITH THE PLACEMENT OF ANOTHER IMPLANT. THE PATIENT DID NOT EXPERIENCE ANY NEGATIVE IMPACT ON HIS HEALTH.
Patient problems: Sinus Perforation
MAUDE report 18146352 ↗InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #25 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 18139896 ↗InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. TOOTH LOCATION 12, 46.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 17875842 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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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