Tapered Screw-Vent® TSVWB8Recalls & 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 implant is a root-form implant placed in bone. Its 414 reports often describe bone loss around the implant, infection, and fractures, and some implants were removed. Reports fell in the most recent 12 months, with 42 compared with 85 in the 12 months before. The reports include no deaths and 373 injuries, and 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
- 415
- Deaths reported
- 0
- Injuries reported
- 374
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 415 adverse event reports that list this exact device (DI 00889024020085), received between May 3, 2019 and Sep 29, 2026 — classified as 374 injuries, 41 malfunctions.
The most frequently reported specific device problem is “Fracture” (29 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 Problem347
- Fracture29
- Separation Failure14
- Mechanical Problem10
- Patient-Device Incompatibility10
- Component Missing5
- Failure to Osseointegrate3
- Loss of Osseointegration3
Patient problems
- Unspecified Infection255
- Osteolysis217
- Pain86
- Inflammation62
- No Clinical Signs, Symptoms or Conditions60
- Abscess24
- No Information21
- Swelling/ Edema20
Recent adverse event reports
The 25 most recent of 415 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929020 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Doctor reported that implant was removed due to Peri-implantitis.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50913256 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that an implant at tooth site 16 was removed due to infection and bone loss.Patient suffered from pain, edema and abscess.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 50912289 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported that an implant was removed due to a bone loss at tooth site 14.
Patient problems: Osteolysis
MAUDE report 50784183 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implant at tooth site #36 was removed due to peri-implantitis. During the impression appointment for crown fabrication, the practitioner noted granulation tissue on the buccal aspect of the implant and probing extending to the apex. Curettage was performed, and bone graft material was placed; however, the condition did not improve, and the implant was subsequently removed.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50771134 ↗InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Osteolysis
MAUDE report 50650611 ↗InjuryJun 11, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 HAD FRACTURED AND WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain
MAUDE report 25476872 ↗InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #2 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 25435257 ↗InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #18 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 25350871 ↗MalfunctionMay 29, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 FRACTURED UPON PLACEMENT AND WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25331484 ↗InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND ABSCESS.
Patient problems: Abscess; Unspecified Infection
MAUDE report 25221343 ↗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. THE PATIENT HAS BEEN EXPERIENCING PERSISTENT PAIN AND RECURRENT INFECTION AROUND TEETH 46 AND 47. DESPITE ATTEMPTS TO CLEAN THE AREA AND REMAKE THE CROWNS, THERE HAS BEEN NO IMPROVEMENT. THE SYMPTOMS HAVE BEEN PRESENT SINCE 2023. IN 2026, LOSS OF INTEGRATION OF IMPLANT 46 AND A CLEARLY VISIBLE PERI-IMPLANTITIS AROUND IMPLANT 47 WERE OBSERVED. PATIENT SUFFERED FROM PAIN AND INFLAMMATION. THIS EVENT REFERS TO THE PERI-IMPLANTITIS CASE.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 25121480 ↗InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER #14 17 22 24 & 27 FAILED DUE TO PERI-IMPLANTITIS. SCRAPING AND NORMAL TREATMENT FOR INFECTION AND INFLAMMATION. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS CORRECTLY CONCLUDED BY PLACING ANOTHER IMPLANT. PAIN AND INFLAMMATION WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24979343 ↗InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER #14 17 22 24 & 27 FAILED DUE TO PERI-IMPLANTITIS. SCRAPING AND NORMAL TREATMENT FOR INFECTION AND INFLAMMATION. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS CORRECTLY CONCLUDED BY PLACING ANOTHER IMPLANT. PAIN AND INFLAMMATION WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24979188 ↗MalfunctionApr 22, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 36 WAS REMOVED DUE TO A FRACTURE OF THE IMPLANT MOUNT INSIDE THE IMPLANT. NO IMPACT ON THE PATIENT REPORTED. PROCEDURE WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24949793 ↗InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE #26 WAS REMOVED DUE TO A PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24936559 ↗MalfunctionApr 9, 2026Separation Failure
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24828736 ↗InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #26 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24801025 ↗InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION AND BONE LOSS. SITE 18 IMPLANT DURING STAGE 2 UNCOVER PROCEDURE, A LOT OF BONE LOSS AND IT DIDN'T TORQUE. THIS SITE ALREADY FAILED ONCE YEARS AGO. NOTED ABSCESS AND PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24790553 ↗InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #26 WAS REMOVED DUE TO INFECTION AND BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: FEVER.
Patient problems: Fever; Osteolysis; Unspecified Infection
MAUDE report 24780941 ↗InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED DUE TO PERI-IMPLANTITIS. THERE WAS A LOSS OF INTEGRATION WITH TISSUE INFILTRATION.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24760887 ↗InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO BONE LOSS AND INFECTION. THE IMPLANT WAS PLACED WITH A STENIAL TECHNIQUE OR ASIP PROTOCOL, CHX RINSE IODINE SERUB AND AM ES 2000MG. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND INFLAMMATION.
Patient problems: Abscess; Osteolysis; Unspecified Infection
MAUDE report 24747180 ↗InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IMPLANT AT TOOTH SITE 27 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 24700656 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT CAME IN WITH DISCOMFORT AROUND THE IMPLANT AT TOOTH SITE #2. THE DOCTOR CHECKED THE IMPLANT AND IT WAS LOOSE. THE TISSUE WAS INFLAMED AND TENDER. THE IMPLANT HAD TO BE REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis
MAUDE report 24681807 ↗InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #47 WAS REMOVED DUE TO PERI-IMPLANTITIS. AT THE 3-MONTH FOLLOW-UP, BONE LOSS WAS OBSERVED AT THE COLLAR OF TOOTH 47, INDICATING A LACK OF OSSEOINTEGRATION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24522475 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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