Tapered Screw-Vent® TSV6B11Recalls & 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 is a ZimVie Tapered Screw-Vent TSV6B11 endosseous dental implant, a screw-shaped replacement tooth root. The 56 reports mostly describe implants that lost bone support or became loose, with infection, inflammation and pain around the implant site, and several implants that fractured or had parts break off; 52 reports involved injuries and no deaths. Forty-four reports simply note the problem occurred without naming a specific device issue. 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
- 54
- Deaths reported
- 0
- Injuries reported
- 50
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00889024019386), received between Nov 27, 2019 and Jun 9, 2026 — classified as 50 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (6 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 Problem42
- Fracture6
- Component Missing2
- Mechanical Problem2
- Loss of Osseointegration1
- Patient-Device Incompatibility1
- Separation Failure1
Patient problems
- Unspecified Infection29
- Osteolysis27
- Pain17
- No Clinical Signs, Symptoms or Conditions9
- Inflammation8
- Abscess6
- No Code Available3
- No Information3
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING CLEANING AFTER THE FINAL CROWN WAS PLACED, BONE LOSS WITH MOBILITY WAS NOTED AROUND THE IMPLANT AT TOOTH SITE #19. THE IMPLANT LOST INTEGRATION AND WAS REMOVED DUE TO PERIIMPLANTITIS. ASPIRATION WAS ALSO NOTED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25448558 ↗InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #46 WAS REMOVED DUE TO PERI-IMPLANTITIS WITH DISTURBED WOUND HEALING.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25446532 ↗InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE # 47 WAS REMOVED DUE TO A PERI-IMPLANTITIS. PATIENT SUFFERED FROM PAIN AND INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 25122025 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS HAVING MAJOR PAIN TO BITING. THERE WERE EXTENSIVE BONE LOSS AND MOBILITY AROUND THE IMPLANT AT TOOTH SITE #2. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24674634 ↗InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS REMOVED DUE TO BONE LOSS. IMPLANT #3 FAILED DURING ROUTINE VISIT. IMPLANT REMOVED PER CLINICIANS' DECISION.
Patient problems: Osteolysis
MAUDE report 24405610 ↗InjuryDec 12, 2025Fracture; Fracture
IT WAS ORIGINALLY REPORTED THAT THE PATIENT PRESENTED TO THE PHYSICIAN IN (B)(6) OF 2025 DUE TO A FRACTURED SCREW IN THE IMPLANT AT TOOTH SITE #19. THE IMPLANT WAS REMOVED AND RETURNED TO THE MANUFACTURER DUE TO A FRACTURED ZIMMER SCREW. THE MANUFACTURER CONFIRMED TO HAVE A FRACTURED COLLAR. THIS WAS DISCOVERED DURING BENCH-TESTING. THE FRACTURED SCREW AS RECORDED AGAINST ANOTHER COMPLAINT AND WAS NOT LOCATED IN THE IMPLANT. THE ZIMMER SCREW WAS NOT RETURNED TO AID IN THE INVESTIGATION. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23794641 ↗InjuryNov 5, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Pain
MAUDE report 23476612 ↗InjuryNov 4, 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: Inflammation; Pain; Unspecified Infection
MAUDE report 23468196 ↗InjuryOct 21, 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 #3, #30 AND #31 WERE REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 23351261 ↗InjuryOct 21, 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 #3, #30 AND #31 WERE REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 23349166 ↗InjuryAug 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED DENTAL IMPLANT FAILED DUE TO INFECTION, TOOTH #30. IT WAS REPORTED BONE LOSS AS SYMPTOMS OF THE EVENT. IMPLANT WAS REMOVED, SITE GRAFTED AND PATIENT WILL RETURN 3 MONTHS FOR NEW IMPLANT PLACEMENT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22880290 ↗InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 36 AND 46 WERE REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21708746 ↗InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A FOLLOW UP APPOINTMENT, AFTER IMPLANT REMOVAL AT TOOTH LOCATION #19, IT WAS NOTED THAT SOFT TISSUE HAD GROWN APICALLY FROM THE OCCLUSAL ASPECT AND THERE WAS NO BONE INTO THE IMPLANT THREADS. THE IMPLANT HAD ALSO LOST INTEGRATION AND WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21355381 ↗InjuryDec 5, 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: Erosion; Osteolysis; Unspecified Infection
MAUDE report 20857493 ↗InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 20754246 ↗MalfunctionAug 12, 2024Component Missing; Component Missing
IT WAS REPORTED VIA EMAIL THAT THE CUSTOMER RECIVED AN IMPLANT WITHOUT AN IMPLANT IN PACKAGING VIAL. NO REPORTED IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19959584 ↗MalfunctionJun 24, 2024Separation Failure; Separation Failure
IT IS REPORTED THAT THE MOUNT (IMPRESSION COPING) IS NOT DISENGAGING FROM THE IMPLANT.SURGERY COMPLETED USING ANOTHER SET OF IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19601780 ↗InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #19 FAILED DUE TO BONE LOSS AND INFECTION. THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19446780 ↗InjuryApr 19, 2024Fracture; Fracture
IT WAS REPORTED THAT THE CROWN FRACTURED CAUSING THE IMPLANT AT TOOTH LOCATION #30 TO FAIL RESULTING IN IMPLANT REMOVAL. UPON FOLLOW-UP, THE CUSTOMER CONFIRMED THAT THE IMPLANT WAS FRACTURED WITH BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Osteolysis
MAUDE report 19148224 ↗InjuryApr 12, 2024Adverse 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. PATIENT WILL HAVE TO RETURN TO PLACE A NEW IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19095085 ↗InjuryMar 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT IN SITE 30 WAS REMOVED DUE TO INFECTION. CAME FOR POST OP APPOINTMENT WITH COMPLAINTS OF SWELLING, PAIN, TENDERNESS TO ADJACENT TEETH. IMPLANT WAS REMOVED AND THE SITE DEBRIDED. NOTED ABSCESS, PAIN AND INFLAMMATION.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 19002665 ↗InjuryJul 10, 2023Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #30 FRACTURED AND WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17291409 ↗InjuryMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AND BONE LOSS AT TOOTH #18 DURING CLINICAL EXAMINATION. THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 16961487 ↗InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS EXTRACTED DUE TO PERI-IMPLANTIS. TOOTH SITE # 4 (UNIVERSAL).
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 16910839 ↗InjuryApr 19, 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 #19 WAS REMOVED DUE TO AN INFECTION. YEARS AFTER CROWN PLACED INFECTION NOTED AROUND IMPLANT WITH BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Abscess; Osteolysis; Unspecified Infection
MAUDE report 16770952 ↗
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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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