Tapered Screw-Vent® TSVH10Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
All models of Tapered Screw-Vent (131)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie Tapered Screw-Vent implant has 193 reports, 168 injuries and no deaths. Many reports describe bone loss, infection and inflammation around the implant, and some describe implants fracturing or being removed. Reports fell from 42 in the prior 12 months to 19 in the most recent 12 months. 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
- 194
- Deaths reported
- 0
- Injuries reported
- 169
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 194 adverse event reports that list this exact device (DI 00889024019560), received between Oct 8, 2019 and Sep 18, 2026 — classified as 169 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Fracture” (41 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem129
- Fracture41
- Unsealed Device Packaging9
- Component Missing7
- Separation Failure6
- Mechanical Problem2
- Appropriate Device Problem Term/Code Not Available1
- Device Damaged by Another Device1
Patient problems
- Osteolysis92
- Unspecified Infection88
- No Clinical Signs, Symptoms or Conditions49
- Pain41
- Inflammation31
- No Information10
- No Code Available7
- Swelling/ Edema7
Recent adverse event reports
The 25 most recent of 194 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Device Damaged by Another Device
It was reported that an implant was removed due to damaged internal hex threads at tooth site 28. The crown had become loose, a new abutment was placed and crown became loose again. Upon inspection, the internal threads were found to be stripped. Patient will have removable partial denture made.Procedure not completed.This report refers to implant with internal threads damaged.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50815928 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Provide detailed description of problem : Patient presented to have implant #20 examined due to discomfort and infection was noted.Patient Impact : No harm to patient.
Patient problems: Discomfort; Unspecified Infection
MAUDE report 50753299 ↗InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #16 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24831418 ↗InjuryMar 31, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED AS IT WAS FRACTURED. PATIENT PRESENTED FOR AN EVALUATION OF IMPLANT #19 AND IT WAS DETERMINED THAT THE IMPLANT WAS FRACTURED. THE IMPLANT WAS LATER REMOVED. THE PATIENT IS EXPECTED TO RETURN FOR A REPLACEMENT ONCE THE GRAFTED BONE IS HEALED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain
MAUDE report 24747473 ↗InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #29 WAS REMOVED DUE TO PERI-IMPLANTITIS. ON (B)(6) THE PATIENT STATED THAT HE WAS SEEN BY A DOCTOR OF DENTAL SERVICES FOR PAIN ASSOCIATED WITH THE IMPLANT AT TOOTH SITE #29. THE DOCTOR PLACED THE PATIENT ON ANTIBIOTICS AND THE PAIN WENT AWAY PER THE PATIENT. THE TISSUE WAS NOTED TO BE SLIGHTLY INFLAMED AND THERE WAS NO MOBILITY. THE BONE LEVEL AROUND THE IMPLANT WAS NOTED TO BE SATISFACTORY AND THE IMPLANT DID NOT REQUIRED REMOVAL AT THAT TIME. ON (B)(6) THE PATIENT RETURNED WITH CONTINUED PROBLEMS AND THE IMPLANT WAS REMOVED. THE PATIENT HAS NOT RETURNED FOR NEW IMPLANT PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24518201 ↗MalfunctionMar 5, 2026Component Missing
THE DOCTOR REPORTS THAT THE IMPLANT CONTAINER ARRIVED EMPTY AND THE PROCEDURE WAS COMPLETED WITH THE PLACEMENT OF OTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24516927 ↗InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Unspecified Infection
MAUDE report 24474103 ↗InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Unspecified Infection
MAUDE report 24473475 ↗InjuryFeb 16, 2026Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24343189 ↗InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #24 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24324717 ↗InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS IN SITE 4 WAS REMOVED DUE TO SEVERE BONE LOSS.
Patient problems: Osteolysis
MAUDE report 24273046 ↗InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS IN SITE 8 WAS REMOVED DUE TO SEVERE BONE LOSS.
Patient problems: Osteolysis
MAUDE report 24272991 ↗InjuryJan 14, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 HAD FRACTURED AND WAS REMOVED. THE PATIENT PRESENTED FOR AN EXAMINATION ON (B)(6) 2025 BECAUSE HE FELT THAT THE IMPLANT HAD CRACKED. THE IMPLANT WAS REMOVED AFTER CONFIRMING THE FRACTURE. THE IMPLANT WILL BE REPLACED ONCE THE BONE GRAFT HAS HEALED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain
MAUDE report 24073155 ↗InjuryDec 16, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23822097 ↗InjuryDec 12, 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 #44 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 23791652 ↗InjuryDec 10, 2025Adverse 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
MAUDE report 23768027 ↗InjuryNov 16, 2025Adverse 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: Pain
MAUDE report 23565698 ↗MalfunctionNov 13, 2025Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT THE GREEN CAP SEAL ON THE VIAL FOR THE IMPLANT IS BROKEN. TO THE SALES REP'S KNOWLEDGE, THE BOX WAS SEALED AND THE BOX WAS NOT TAMPERED WITH. THE DOCTOR JUST OPENED THE PACKAGE FOR A PROCEDURE AND THE GREEN SEAL WAS BROKEN. NO IMPACT TO THE PATIENT AS ANOTHER IMPLANT WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23542479 ↗InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Discomfort; Osteolysis; Pain
MAUDE report 23485598 ↗InjuryNov 5, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23480625 ↗InjuryOct 31, 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 #4 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23439876 ↗InjuryOct 28, 2025Adverse 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: Discomfort; Osteolysis; Unspecified Infection
MAUDE report 23407793 ↗InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS SIGNIFICANT BONE LOSS AROUND THE IMPLANT AT TOOTH SITE #20. THIS WAS NOTED DURING AN EXAM. PER INDICATED: SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. ADDITIONAL APPOINTMENT REQUIRED: YES, POST OP AFTER REPLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: NOT INDICATED.
Patient problems: Osteolysis
MAUDE report 23359471 ↗MalfunctionOct 21, 2025Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH # 30 FRACTURED AT THE CREST THE DOCTOR DOES NOT KNOW YET WHAT COURSE OF ACTION WILL BE TAKEN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23348500 ↗InjuryOct 17, 2025Adverse 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: Pain; Unspecified Infection
MAUDE report 23322586 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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