Screw-Vent ® SVMB10Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
All models of Screw-Vent (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00889024018129), received between Jul 27, 2020 and Apr 22, 2025 — classified as 17 injuries.
The most frequently reported specific device problem is “Fracture” (2 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 Problem15
- Fracture2
- Loss of Osseointegration1
Patient problems
- Osteolysis12
- Unspecified Infection10
- Inflammation6
- Pain4
- Abscess2
- Fistula2
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗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 ↗InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT IN TOOTH SITE #12 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 19315630 ↗InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT IN TOOTH SITE # 35 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 19315584 ↗InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT IN TOOTH SITE #36 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 19315528 ↗InjuryMay 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: Osteolysis
MAUDE report 19291341 ↗InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: Unspecified Infection
MAUDE report 18977672 ↗InjuryAug 11, 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 # 24 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE SITE PRESENTED INFLAMMATION AND EDEMA.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 17514943 ↗InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER #12 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS INFLAMMATION. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 15774474 ↗InjuryApr 28, 2022Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #29 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA, INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 14239240 ↗InjuryDec 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITES #3 AND 4 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WERE REMOVED. THE TISSUE AROUND THE IMPLANTS WERE BOGGY, RED AND INFLAMED AND A DRAINING FISTULA WAS APPROXIMATELY 5MM FROM THE GINGIVAL MARGIN AND THE MID BUCCAL ANTERIOR IMPLANT WAS VERY SENSITIVE AND BLEEDING ON PROBING AND THERE WAS AT LEAST 6MM OF CIRCUMFERENTIAL PROBING DEPTH. SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS, INFECTION, ABSCESS, FISTULA AND INFLAMMATION.
Patient problems: Abscess; Fistula; Inflammation; Osteolysis; Unspecified Infection
MAUDE report 12975287 ↗InjuryDec 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITES #3 AND 4 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WERE REMOVED. THE TISSUE AROUND THE IMPLANTS WERE BOGGY, RED AND INFLAMED AND A DRAINING FISTULA WAS APPROXIMATELY 5MM FROM THE GINGIVAL MARGIN AND THE MID BUCCAL ANTERIOR IMPLANT WAS VERY SENSITIVE AND BLEEDING ON PROBING AND THERE WAS AT LEAST 6MM OF CIRCUMFERENTIAL PROBING DEPTH. SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS, INFECTION, ABSCESS, FISTULA AND INFLAMMATION.
Patient problems: Abscess; Fistula; Inflammation; Osteolysis; Unspecified Infection
MAUDE report 12975282 ↗InjuryMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IMPLANT AT TOOTH LOCATION #18 WAS REMOVED DUE TO PERI-IMPLANTITIS, PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 11792613 ↗InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO AN INFECTION, ANTIBIOTICS WERE PRESCRIBED.
Patient problems: Unspecified Infection
MAUDE report 11342121 ↗InjuryJul 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IMPLANT REMOVED DUE TO PERI-IMPLANTITIS. PATIENT ALSO HAD INFLAMMATION AND PAIN.
Patient problems: Inflammation; No Code Available; Pain; Unspecified Infection
MAUDE report 10325078 ↗
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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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