Screw-VentRecalls & reported problems across all models
ZimVie US Corp LLC · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 73
- Deaths reported
- 0
- Injuries reported
- 73
- Recalls
- 0
We found 15 models of Screw-Vent by ZimVie US Corp LLC in the FDA's device registry (GUDID). Together they are named in 73 adverse event reports in the FDA's MAUDE database, received between Mar 16, 2020 and Dec 16, 2025 — classified as 73 injuries.
The most frequently reported specific device problem is “Fracture” (10 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Screw-Vent problems
Device problems
- Adverse Event Without Identified Device or Use Problem62
- Fracture10
- Loss of Osseointegration1
- Mechanical Problem1
Patient problems
- Unspecified Infection47
- Osteolysis46
- Inflammation15
- Pain13
- No Clinical Signs, Symptoms or Conditions10
- Swelling/ Edema5
- Abscess4
- Fistula2
Screw-Vent models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Screw-Vent ® SVMB13IMPLANT, ENDOSSEOUS, ROOT-FORM23 reports
- Screw-Vent ® SVMB10IMPLANT, ENDOSSEOUS, ROOT-FORM17 reports
- Screw-Vent ® SVB10IMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- Screw-Vent ® SVB13IMPLANT, ENDOSSEOUS, ROOT-FORM5 reports
- Screw-Vent ® SVMB16IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- Screw-Vent® SVMH10IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- Screw-Vent® SVH13IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- Screw-Vent ® SVMB8IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- Screw-Vent® SVMH16IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- Screw-Vent ® SVWB10IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- Screw-Vent ® SVWB13IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- Screw-Vent® SVWH10IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- Screw-Vent ® SVB16IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- Screw-Vent® SVH10IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- Screw-Vent® SVMH8IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
Recent Screw-Vent adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryDec 16, 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: Osteolysis
MAUDE report 23821220 ↗InjuryDec 15, 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 #33 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 23803077 ↗InjuryJun 20, 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 DENTAL POSITION NUMBER #44 FAILED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22301291 ↗InjuryApr 22, 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 #46 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 21882996 ↗InjuryApr 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 #14 & #15 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 21771347 ↗InjuryApr 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 #14 & #15 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 21771318 ↗InjuryMar 17, 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 POSITION NUMBER #32 #33 #42 #35 AND #45 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. THE DOCTOR REPORTED INFLAMMATION AND EDEMA.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 21619099 ↗InjuryMar 17, 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 POSITION NUMBER #32 #33 #42 #35 AND #45 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. THE DOCTOR REPORTED INFLAMMATION AND EDEMA.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 21619020 ↗InjuryMar 17, 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 POSITION NUMBER #32 #33 #42 #35 AND #45 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. THE DOCTOR REPORTED INFLAMMATION AND EDEMA.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 21619007 ↗InjuryMar 17, 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 POSITION NUMBER #32 #33 #42 #35 AND #45 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. THE DOCTOR REPORTED INFLAMMATION AND EDEMA.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 21618985 ↗InjuryJan 31, 2025Fracture; Fracture
FRACTURED IMPLANT, TOOTH #19. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain
MAUDE report 21287012 ↗InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20557613 ↗InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis; Pain
MAUDE report 20256361 ↗InjuryJul 26, 2024Fracture; Fracture
DOCTOR REPORTED IMPLANT FRACTURE AT TOOTH SITE 36. IMPLANT WAS REHABILITATED FOR 3,5 YEARS, THEN THE IMPLANT COLLAR FRACTURED AND CROWN FELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19836928 ↗InjuryJul 26, 2024Mechanical Problem; Mechanical Problem
THE DOCTOR REPORTS THAT HEXAGON IS DAMAGED. IMPLANT WAS REMOVED. PROCEDURE NOT COMPLETED WITH OTHER IMPLANT. AFFECTED BONE TYPE III AND DENTAL POSITION IS 13.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19836426 ↗
Other ZimVie US Corp LLC products
- Tapered Screw-Vent131 models · 13,236 reports · 4 recalls
- OSSEOTITE CERTAIN74 models · 1,891 reports · 1 recall
- TSX Implants28 models · 1,279 reports
- OSSEOTITE73 models · 894 reports
- 3i T3 DCD73 models · 789 reports
- OSSEOTITE CERTAIN PREVAIL15 models · 785 reports
- CERTAIN BELLATEK12 models · 9 reports · 10 recalls
- Eztetic15 models · 382 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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