Tapered Screw-Vent® TSV4B13Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
All models of Tapered Screw-Vent (131)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie Tapered Screw-Vent dental implant is placed in the jawbone to hold a replacement tooth. Its 216 reports include 202 injuries and no deaths. Most reports mention infection or bone loss around the implant, and recent ones describe implants removed for this reason, while others describe the implant fracturing. 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
- 219
- Deaths reported
- 0
- Injuries reported
- 205
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 219 adverse event reports that list this exact device (DI 00889024019249), received between Oct 3, 2019 and Sep 29, 2026 — classified as 205 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Fracture” (21 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 Problem186
- Fracture21
- Component Missing5
- Separation Failure3
- Unsealed Device Packaging3
- Loss of Osseointegration2
- Mechanical Problem2
- Packaging Problem1
Patient problems
- Unspecified Infection131
- Osteolysis90
- Pain62
- No Clinical Signs, Symptoms or Conditions38
- Inflammation35
- No Information22
- Swelling/ Edema10
- No Code Available9
Recent adverse event reports
The 25 most recent of 219 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported the patient experienced a failed implant in 2024. A new implant was placed on (b)(6)2025, but the implant site became infected again. The implants were removed and debridement was performed on (b)(6)2025. Tooth site 11,21,25. Implants were removed due to peri-implantitis.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50931183 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Doctor reported that implant was removed due to Peri-implantitis. Patient has been rescheduled for new prosthetic.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50913214 ↗InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
It was reported significant bone loss due to peri implantitis, tooth sites 13 and 14.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50691736 ↗InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
It was reported a patient with infection post control, at tooth site 13.
Patient problems: Unspecified Infection
MAUDE report 50690250 ↗InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem
It was reported implant at tooth location 25 was removed due to periimplantitis.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50668275 ↗InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem
It was reported that peri-implantitis was identified at implant sites 12, 22, 15, 25, and 32 during a clinical procedure. The affected implants were removed, and no harm to the patient was reported.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50516494 ↗InjuryJun 4, 2026Fracture
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER 34 FAILED BECAUSE IT FRACTURED AT THE BODY. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. BONE TYPE: II.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25391543 ↗InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #24 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 25301656 ↗InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #15 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 25301087 ↗InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #43 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25285044 ↗InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #34 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24830954 ↗InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #7, #9 AND #11 WERE REMOVED AS THE IMPLANTS WERE NOT IN A POSITION FOR PROPOSED IMPLANT SUPPORTED FULL DENTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24778942 ↗InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #18 WAS REMOVED DUE TO ALLERGIC REACTION AND PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.
Patient problems: Hypersensitivity/Allergic reaction; Osteolysis; Unspecified Infection
MAUDE report 24747388 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #10 HAD FAILED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 24734663 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #41 WAS REMOVED DUE TO PERI-IMPLANTITIS. NO OTHER IMPLANT WAS PLACED DURING THE SAME PROCEDURE.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24681205 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis
MAUDE report 24676627 ↗InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS. IMPLANT PLACED BY DR. WITH STERING TECHNIQUE WITH ASPIP PROTOCOL. CHX RINSE IODINE SERUB AMAZ 2000 MG. TOOTH #'S 3 SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis
MAUDE report 24631184 ↗InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #5 WAS PLACED WITH STERILE TECHNIQUE ACCORDING TO PROTOCOL AND CHX RINSE, SCRUB IODINE AND AMOXICILLIN, 2000MG. INFECTION WAS NOTED AND THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND INFLAMMATION.
Patient problems: Abscess; Osteolysis; Unspecified Infection
MAUDE report 24627339 ↗InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANTS AT TOOTH SITES 15 AND 25 WERE REMOVED DUE TO PERI-IMPLANTITIS. PATIENT EXPERIENCED PAIN, DISCOMFORT AND INFLAMMATION.
Patient problems: Discomfort; Osteolysis; Unspecified Infection
MAUDE report 24606607 ↗InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANTS AT TOOTH SITES 15 AND 25 WERE REMOVED DUE TO PERI-IMPLANTITIS. PATIENT EXPERIENCED PAIN, DISCOMFORT AND INFLAMMATION.
Patient problems: Discomfort; Osteolysis; Unspecified Infection
MAUDE report 24606578 ↗InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT RETURNED WITH PAIN AND MOBILITY AT THE IMPLANT OF TOOTH SITE #13. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.
Patient problems: Abscess; Inflammation; Unspecified Infection
MAUDE report 24596205 ↗InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #36 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 24523931 ↗InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED DUE TO PAIN ON THE IMPLANT BRIDGE AT TOOTH SITES #21-23. IT WAS NOTED THAT THE PATIENT HAD INFECTION AND MOBILITY AROUND THE IMPLANTS. THE BRIDGE WAS REMOVED AND THE AREA WAS DEGRANULATED. THE AREAS WERE ALLOWED TO HEAL AND THE PATIENT OPTED TO HAVE A PARTIAL CRAFTED, RATHER THAN HAVING THE IMPLANT BRIDGE REMADE. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Abscess; Osteolysis; Unspecified Infection
MAUDE report 24378139 ↗InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #12 AND #26 WERE REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 24367370 ↗InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES # 35 AND #36 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24308019 ↗
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- 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
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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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