OSSEOTITE® OSS310Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® IMPLANT 3.75 X 10MM · Class 2 · Implant
Quick summary
This ZimVie OSSEOTITE dental implant is a small screw-shaped root-form implant. The 54 reports mostly describe implants that fractured or broke, plus infections and bone loss around the implant site that led to removal; 52 reports involved injuries and no deaths were reported. Most recent accounts mention implants breaking at the head or body, some with the lower piece left in place, along with pain and inflammation. 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
- 55
- Deaths reported
- 0
- Injuries reported
- 53
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00844868013105), received between Jan 15, 2020 and Jul 28, 2026 — classified as 53 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (30 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture30
- Adverse Event Without Identified Device or Use Problem21
- Mechanical Problem2
- Patient-Device Incompatibility1
- Unsealed Device Packaging1
Patient problems
- Unspecified Infection19
- No Clinical Signs, Symptoms or Conditions18
- Osteolysis18
- Pain12
- Inflammation7
- No Information7
- No Code Available5
- Swelling/ Edema2
Recent adverse event reports
The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.
InjuryJul 28, 2026Patient-Device Incompatibility
The doctor reports that the dental implant failed due to Allergic reactoin.The doctor reports in the PER that the procedure was concluded..
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 50054352 ↗InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #15 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 25187074 ↗InjuryDec 11, 2025Fracture; Fracture
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER #47 FAILED BECAUSE IT FRACTURED AT THE HEAD. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT, PATIENT WILL RETURN TO PLACE A NEW IMPLANT ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23778980 ↗InjuryNov 17, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23568364 ↗InjuryNov 17, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23568263 ↗InjuryAug 28, 2025Mechanical Problem; Mechanical Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22910825 ↗InjuryJul 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS. TOOTH SITES #14, #15.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22550223 ↗MalfunctionJul 14, 2025Fracture; Fracture
IT WAS REPORTED AN IMPLANT FRACTURE BY THE IMPLANT BODY. THE PROCESS WAS NOT COMPLETED WITH ANOTHER IMPLANT. ONLY THE UPPER PART WAS RETURNED, THE LOWER PART WAS NOT REMOVED DUE TO IMPLANT POSITION AND WAS PUT TO SLEEP. PAIN AND INFLAMMATION WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: Inflammation; Pain
MAUDE report 22492329 ↗InjuryJun 24, 2025Fracture; Fracture
DOCTOR REPORTED THAT IMPLANT FRACTURED AND ABUTMENT SCREW FRACTURED AT TOOTH SITE 44, SO THAT BRIDGE FELL OUT A YEAR AND 2 MONTHS AFTER PROSTHETIC TREATMENT AND IMPLANT WAS REMOVED. THE PROCEDURE LASTED LONGER, AS IMPLANT HAD TO BE RE-DRILLED. PATIENT HAS BEEN RESCHEDULED FOR NEW IMPLANT PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22321235 ↗InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 45 WAS REMOVED DUE TO BONE LOSS WITH ABSCESS.
Patient problems: Osteolysis
MAUDE report 21772086 ↗InjuryJan 13, 2025Adverse 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 PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21135944 ↗InjuryDec 7, 2024Adverse 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 #15 & #16 FAILED DUE TO PERI-IMPLANTITIS DISCOVERED DURING X-RAY CHECK UP. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. ABSCESS WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20873579 ↗InjuryNov 18, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20706783 ↗InjuryOct 24, 2024Fracture; Fracture
IT WAS REPORTED AN IMPLANT FRACTURE AT THE BOTTOM. SURGERY WAS NEEDED TO COMPLETELY REMOVED THE IMPLANT. NO OTHER IMPACT ON THE PATIENT REPORTED. TOOTH SITE #46.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20521265 ↗InjuryAug 27, 2024Fracture; Fracture
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER #37 FAILED BECAUSE IT FRACTURED BY THE HEAD AND BONE LOSS WAS OBSERVED. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. BONE TYPE: UNKNOWN. THE DOCTOR REPORTED : PAIN
Patient problems: Osteolysis; Pain
MAUDE report 20074250 ↗InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 24 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT REFERRED PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 19825309 ↗InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 32, 42 WERE REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19611855 ↗InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 32, 42 WERE REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19611851 ↗InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SIGNIFICANT PAIN APPEARS THREE DAYS AFTER IMPLANT PLACEMENT, REQUIRING REMOVAL, TOOTH #44.
Patient problems: Pain
MAUDE report 19144911 ↗InjuryMar 18, 2024Fracture; Fracture
DOCTOR REPORTED IMPLANT FRACTURE AT TOOTH SITE 47. PATIENT REFERRED PAIN. VERY HARD MANDIBULAR RAMUS AND BONE. AN ADDITIONAL APPOINTMENT WAS NECESSARY TO REMOVE THE REMAINING PART OF THE FRACTURED IMPLANT.
Patient problems: Pain
MAUDE report 18923442 ↗MalfunctionNov 16, 2023Unsealed Device Packaging; Unsealed Device Packaging
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18146314 ↗InjuryOct 24, 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 22 WAS REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION AND PAIN WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 17993765 ↗InjuryOct 4, 2023Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17868818 ↗InjurySep 22, 2023Fracture; Fracture
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER #46 FAILED BECAUSE IT FRACTURED AT THE HEAD. THE DOCTOR REPORTED THAT THE IMPLANT BROKE 4MM BELOW THE BONE CREST. THE DOCTOR REPORTS THAT THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17796744 ↗InjuryAug 11, 2023Adverse 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: Pain; Unspecified Infection
MAUDE report 17513399 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.