Screw-Vent ® SVMB13Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Screw-Vent dental implant is a root-form implant placed in the jaw to support dental work. The 23 reports describe infections around the implant with swelling, pain and bone loss, often with the implant loosening, failing and being removed, and a few mention fracture. The reports include no deaths and 23 injuries. 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
- 23
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00889024018136), received between Nov 2, 2020 and Mar 17, 2025 — classified as 23 injuries.
The most frequently reported specific device problem is “Fracture” (5 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem18
- Fracture5
Patient problems
- Unspecified Infection15
- Osteolysis14
- No Clinical Signs, Symptoms or Conditions5
- Pain5
- Swelling/ Edema4
- Abscess2
- Inflammation2
- Edema1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjuryMar 17, 2025Adverse 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 POSITION NUMBER #32 #33 #42 #35 AND #45 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. THE DOCTOR REPORTED INFLAMMATION AND EDEMA.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 21619099 ↗InjuryMar 17, 2025Adverse 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 POSITION NUMBER #32 #33 #42 #35 AND #45 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. THE DOCTOR REPORTED INFLAMMATION AND EDEMA.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 21619020 ↗InjuryMar 17, 2025Adverse 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 POSITION NUMBER #32 #33 #42 #35 AND #45 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. THE DOCTOR REPORTED INFLAMMATION AND EDEMA.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 21619007 ↗InjuryMar 17, 2025Adverse 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 POSITION NUMBER #32 #33 #42 #35 AND #45 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. THE DOCTOR REPORTED INFLAMMATION AND EDEMA.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 21618985 ↗InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19271548 ↗InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19271448 ↗InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A LOSS OF INTEGRATION DUE TO A PERI IMPLANTITIS AROUND TEETH 23 AND 24.IMPLANTS WERE REMOVED AND NO OTHER IMPLANTS WERE PLACED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 18245657 ↗InjuryNov 30, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18242172 ↗InjuryOct 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 17935992 ↗InjuryFeb 6, 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 #25 LOST INTEGRATION DUE TO SIGNIFICANT BONE LOSS AND INFECTION AT THE IMPLANT SITE. THE IMPLANT WAS REMOVED DUE TO PERIIMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 16303495 ↗InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PERIODONTAL INFECTION ON IMPLANT SVMB13 TOOTH # 9. IMPLANT WAS REMOVED.
Patient problems: Unspecified Infection
MAUDE report 15341830 ↗InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR INDICATED BONE LOSS AT TOOTH SITE #13 AND THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis
MAUDE report 15336565 ↗InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR INDICATED BONE LOSS AT TOOTH SITE #11 AND THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis
MAUDE report 15335807 ↗InjuryJul 7, 2022Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED BECAUSE IT WAS FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14948412 ↗InjuryMay 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS AND BONE LOSS. PATIENT WOULD RETURN FOR RE-IMPLANTATION.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 14425087 ↗InjuryApr 13, 2022Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BECOMING FRACTURED. TOOTH #23.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14106433 ↗InjuryMar 24, 2022Fracture; Fracture
IT WAS REPORTED IMPLANTS WERE REMOVED DUE TO FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13887755 ↗InjuryDec 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS WITH IMPLANT MOBILITY, PAIN AND AN ABSCESS. PATIENT WILL NOT RETURN FOR ADDITIONAL APPOINTMENTS.
Patient problems: Abscess; Osteolysis; Pain; Unspecified Infection
MAUDE report 13064255 ↗InjuryDec 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED INFECTION. PATIENT RETURNED WITH PAIN ON THE IMPLANT, SECRETION WAS OBSERVED. PAIN AND INFLAMMATION ARE REPORTED AS CONSEQUENCES OF THE INFECTION.TOOTH SITE # 13.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 13040053 ↗InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BONE LOSS AND PAIN AT THE SITE. TOOTH #10.
Patient problems: Osteolysis; Pain
MAUDE report 12923850 ↗InjuryOct 22, 2021Fracture; Fracture
DOCTOR REPORTED THE IMPLANT FRACTURED AND WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12681349 ↗InjurySep 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: Abscess; Pain; Unspecified Infection
MAUDE report 12425537 ↗InjuryNov 2, 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: Edema; Inflammation; Pain; Unspecified Infection
MAUDE report 10769262 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page