Tapered Screw-Vent® TSVH13Recalls & 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 dental implant is placed in the jawbone to hold a replacement tooth. Many of its 103 reports describe implants becoming loose, falling out, or being removed because of infection around the implant and bone loss. The reports mention no deaths and 99 injuries. Reports fell to 5 in the last 12 months, from 28 in the 12 months before. 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
- 103
- Deaths reported
- 0
- Injuries reported
- 99
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI 00889024019584), received between Jun 25, 2020 and Feb 23, 2026 — classified as 99 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (11 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 Problem86
- Fracture11
- Unsealed Device Packaging3
- Component Missing1
- Detachment of Device or Device Component1
- Patient-Device Incompatibility1
Patient problems
- Unspecified Infection64
- Osteolysis45
- Pain24
- Inflammation19
- No Clinical Signs, Symptoms or Conditions17
- Erosion7
- No Code Available7
- Swelling/ Edema6
Recent adverse event reports
The 25 most recent of 103 reports, in the reporter's own words as published by the FDA.
InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #26 FELL OUT DUE TO PERI-IMPLANTITIS. PATIENT CALLED AND STATED IMPLANT FELL OUT. NEW IMPLANT PLACED ON 7/16 IN #27 POSITION.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24422026 ↗InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW-UP ON THE IMPLANT AT TOOTH SITE #11. THE IMPLANT WAS FOUND LOOSE WITH PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24278447 ↗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; Pain
MAUDE report 23770909 ↗MalfunctionNov 17, 2025Component Missing; Component Missing
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23568276 ↗InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #10 & #11 WERE REMOVED DUE TO BONE LOSS. THE PATIENT CAME IN WITH DISCOMFORT AROUND THE IMPLANTS. THE IMPLANTS WERE REMOVED WITH A TORQUE WRENCH.
Patient problems: Osteolysis
MAUDE report 23501055 ↗InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2024, THE PATIENT CAME IN TO THE OFFICE FOR EVALUATION OF IMPLANT #29, WHICH WAS PLACED ON (B)(6) 2010. THE PATIENT PRESENTED FOR AN EXAMINATION AND IT WAS NOTED THAT EXUDATE WAS PRESENT AND THE IMPLANT REMOVAL WAS RECOMMENDED. THE IMPLANT WAS REMOVED AND GRAFTED FOR POSSIBLE FUTURE IMPLANT.
Patient problems: Osteolysis
MAUDE report 23317242 ↗InjuryAug 19, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22840951 ↗InjuryAug 4, 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 POSITIONS NUMBER 16 AND 17 FAILED DUE TO PERI-IMPLANTITIS ON SINUS LIFT. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22707330 ↗InjuryAug 4, 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 POSITIONS NUMBER 16 AND 17 FAILED DUE TO PERI-IMPLANTITIS ON SINUS LIFT. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.
Patient problems: Inflammation; Osteomyelitis; Unspecified Infection
MAUDE report 22706819 ↗InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER #15 FAILED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22663016 ↗InjuryJul 29, 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 #24 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22650332 ↗InjuryJul 29, 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 #12 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22650126 ↗MalfunctionJul 26, 2025Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT IMPLANT VIAL CAP BROKEN. WHEN THE IMPLANT CONTAINER WAS REMOVED FROM THE CASE, THE CAP (GREEN) WAS CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22621516 ↗MalfunctionJul 24, 2025Unsealed Device Packaging; Unsealed Device Packaging
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22586875 ↗InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DENTAL IMPLANTS LOCATED IN UNKNOWN DENTAL POSITIONS FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTED INFLAMMATION, ABSCESS, AND EDEMA.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22463465 ↗InjuryJul 3, 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 #13 WAS PLACED WITH A SINUS LIFT. A CT TAKEN AFTER SHOWED LARGE VOIDS AROUND THE IMPLANT. THE IMPLANT WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 22393815 ↗InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH #11 WAS REMOVED DUE TO INFECTION. IMPLANT AREA WAS INFECTED AT POSTOPERATIVE APPOINTMENT. IMPLANT WAS MOBILE. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, EDEMA, INFLAMMATION, PAIN AND SWELLING.
Patient problems: Erosion; Swelling/ Edema; Unspecified Infection
MAUDE report 22353088 ↗InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #7, #8, #9 AND #10 WERE REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.
Patient problems: Erosion; Pain; Unspecified Infection
MAUDE report 22341548 ↗InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #7, #8, #9 AND #10 WERE REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.
Patient problems: Erosion; Pain; Unspecified Infection
MAUDE report 22341488 ↗InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #7, #8, #9 AND #10 WERE REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.
Patient problems: Erosion; Pain; Unspecified Infection
MAUDE report 22341263 ↗InjuryJun 24, 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 #6 WAS REMOVED DUE TO INFECTION. PATIENT PRESENTED FOR A TWO-MONTH POST-OPERATIVE VISIT AND INFECTION WAS NOTED. PATIENT WAS THEN SCHEDULED FOR THE REMOVAL OF THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN, SWELLING
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 22325082 ↗InjuryJun 19, 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 #12 WAS REMOVED DUE TO BONE LOSS AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 22293419 ↗InjuryJun 19, 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 #12 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 22293328 ↗InjuryJun 18, 2025Fracture; Fracture
IT WAS REPORTED THAT THE DENTIST PERFORMED A 6 MONTH VISIT & DURING EXAM DISCOVERED A FRACTURE (FX) OF THE IMPLANT AT TOOTH SITE #19. THE IMPLANT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22284162 ↗InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT COMPLAINED OF PAIN AT IMPLANT SITE #29. PANORAMIC X-RAY SHOWED NO REASON FOR PAIN. DDS SENT PA X-RAY SHOWING ROOT TIP AT #29. IMPLANT AND ROOT TIP WERE REMOVED. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: IMPLANT REMOVED. TOOTH SITE: 29. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain
MAUDE report 22077866 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
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- 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 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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