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Tapered Screw-Vent® TSVMWH11Recalls & 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

Adverse event reports
8
Deaths reported
0
Injuries reported
8
Recalls naming it
0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024344150), received between Dec 20, 2019 and Jan 23, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem7
  • Fracture1

Patient problems

  • Unspecified Infection6
  • Osteolysis4
  • Inflammation2
  • Abscess1
  • Erosion1
  • Failure of Implant1
  • Sensitivity of Teeth1

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #20 WAS REMOVED DUE TO MOBILITY ASSOCIATED WITH PERI-IMPLANTITIS. AN ADDITIONAL APPOINTMENT WAS REQUIRED TO REPLACE THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

    Patient problems: Erosion; Osteolysis; Unspecified Infection

    MAUDE report 24164813 ↗
  • InjuryNov 11, 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 #8 DID NOT HEAL AND BONE DID NOT FILL IN AROUND THE IMPLANT. THERE WAS ACTIVE INFECTION PRIOR TO PLACEMENT THAT MAY HAVE BEEN THE CAUSING FACTOR. THE IMPLANT WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

    Patient problems: Inflammation; Osteolysis

    MAUDE report 23523435 ↗
  • InjuryApr 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 #5 WAS REMOVED DUE TO INFECTION.

    Patient problems: Unspecified Infection

    MAUDE report 21770249 ↗
  • InjuryAug 18, 2022Fracture; Fracture

    NO EVENT WAS REPORTED BY THE CUSTOMER HOWEVER THE IMPLANT WAS RECEIVED FRACTURED AT THE IMPLANTS HEAD.

    Patient problems: Failure of Implant

    MAUDE report 15253006 ↗
  • InjuryJul 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT AT A 1 MONTH TISSUE CHECK, THE PATIENT HAS PERI-IMPLANTITIS, SENSITIVITY AND INFLAMMED TISSUES AROUND THE IMPLANT AT TOOTH LOCATION #4.

    Patient problems: Inflammation; Osteolysis; Sensitivity of Teeth; Unspecified Infection

    MAUDE report 14982172 ↗
  • InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES # 19 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AT THE IMPLANT SITE AND WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS.

    Patient problems: Osteolysis; Unspecified Infection

    MAUDE report 12619088 ↗
  • InjuryJul 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT IMPLANT AT TOOTH SITE # 6 WAS REMOVED DUE TO INFECTION. PATIENT TO RETURN FOR IMPLANT RE-PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION AND ABSCESS.

    Patient problems: Abscess; Unspecified Infection

    MAUDE report 10236687 ↗
  • InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT AN IMPLANT (TSVMWH11) WAS REMOVED DUE TO INFECTION. SITE WAS BONE GRAFTED.

    Patient problems: Unspecified Infection

    MAUDE report 9503664 ↗

Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices

All IMPLANT, ENDOSSEOUS, ROOT-FORM devices →

Sources and updates

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