OSSEOTITE® OSS385Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® IMPLANT 3.75 X 8.5MM · Class 2 · Implant
All models of OSSEOTITE (73)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00844868013167), received between Sep 7, 2020 and Sep 30, 2026 — classified as 8 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Device Damaged by Another Device” (3 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 Problem5
- Device Damaged by Another Device3
- Fracture3
- Loss of Osseointegration1
Patient problems
- No Information4
- Unspecified Infection3
- No Clinical Signs, Symptoms or Conditions2
- Osteolysis2
- Pain2
- Erosion1
- Inflammation1
- No Code Available1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Fracture; Loss of Osseointegration
The doctor reports that the dental implants failed because they fractured by the head & body. Loss of integration was also reported. Tooth sites 24 and 25.The doctor reports that the procedure was not concluded by placing another implants.Bone type: III.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946394 ↗InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #35 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN.
Patient problems: Erosion; Pain; Unspecified Infection
MAUDE report 24054153 ↗InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 23950560 ↗InjuryNov 25, 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 #35 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 23648916 ↗InjuryJun 21, 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 AN UNKNOWN DENTAL POSITION FAILED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22303519 ↗InjuryAug 26, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20063253 ↗InjuryDec 1, 2020Adverse 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: No Code Available
MAUDE report 10926426 ↗MalfunctionOct 23, 2020Device Damaged by Another Device; Device Damaged by Another Device
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 10725158 ↗MalfunctionOct 23, 2020Device Damaged by Another Device; Device Damaged by Another Device
IT WAS REPORTED THAT IN FEBRUARY AN IMPLANT WAS PLACED WITH A COVER SCREW. IN SEPTEMBER, A DOCTOR PERFORMED THE SECOND SURGERY, AND REMOVED THE COVER SCREW TO TAKE IMPRESSIONS. DOCTOR TOOK IMPRESSIONS WITH NO INCIDENCE, AND WHEN PLACING THE HEALING ABUTMENT, IT DID NOT SCREW INTO THE IMPLANT. DOCTOR RE-DO THE INTERNAL THREADS OF THE IMPLANT, AND IMPLANT REMAINS PLACED.
Patient problems: No Information
MAUDE report 10725101 ↗MalfunctionOct 23, 2020Device Damaged by Another Device; Device Damaged by Another Device
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 10725062 ↗InjurySep 7, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 10499152 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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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