CERTAIN® IUNIHTRecalls & reported problems
ZimVie US Corp LLC · CERTAIN® TITANIUM HEXED SCREW · Class 2 · Implant
Quick summary
This ZimVie CERTAIN® IUNIHT is a titanium screw used to anchor a dental implant crown. The 64 reports mostly describe the screw breaking or coming loose, with some patients reporting pain, bone loss around the implant, or discoloration at the gum; nine reports involved an injury and no deaths were reported. 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
- 67
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00844868008545), received between Feb 4, 2020 and Sep 29, 2026 — classified as 8 injuries, 59 malfunctions.
The most frequently reported specific device problem is “Fracture” (48 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
- Fracture48
- Unintended Movement18
- Loose or Intermittent Connection2
Patient problems
- No Clinical Signs, Symptoms or Conditions53
- No Information7
- Pain4
- Insufficient Information3
- Discomfort1
- Inflammation1
- No Code Available1
- Osteolysis1
Recent adverse event reports
The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Fracture
It was reported the patient presented with the crown and fractured screws. The screws had fractured at the head, with the fractured head remaining inside the crown, while the remaining portion of the screws had not only become detached but had also unscrewed and was found in the patient¿s mouth. Tooth site 36. Placed on (b)(6)2026 and removed on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930159 ↗MalfunctionSep 29, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929410 ↗MalfunctionSep 29, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929393 ↗MalfunctionSep 29, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929373 ↗MalfunctionApr 13, 2026Unintended Movement
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 27 WAS REMOVED DUE TO BONE LOSS AND INFECTION. PATIENT REFERRED PAIN. CROWN LOOSENING WAS ALSO REPORTED. THIS COMPLAINT REFERS TO THE LOOSENING OF THE SCREW EVENT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24857121 ↗MalfunctionApr 13, 2026Unintended Movement
DOCTOR REPORTED SCREW LOOSENING AT TOOTH SITES 35 AND 37. PLACEMENT DATE: (B)(6) 2026, REMOVAL DATE (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24856801 ↗MalfunctionApr 13, 2026Unintended Movement
DOCTOR REPORTED SCREW LOOSENING AT TOOTH SITES 35 AND 37. PLACEMENT DATE: (B)(6) 2026, REMOVAL DATE: (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24856763 ↗MalfunctionMar 16, 2026Fracture
DOCTOR REPORTED ONE FRACTURED SCREW THAT COULD NOT BE REMOVED FROM IMPLANT (TIP PART NOT RETURNED TO ZIMVIE) AND IMPLANT WILL NOT BE REMOVED. FIVE SCREWS THAT PRESENTED DISCOLORATION ONTO THE GUMS WERE EXCHANGED FOR NEW ONES. SCREWS REMOVED ON (B)(6) 2026. THIS COMPLAINT REFERS TO THE FRACTURE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24603565 ↗MalfunctionMar 12, 2026Unintended Movement
IT WAS REPORTED THAT THE SCREWS WERE LOOSENED AND DID NOT HOLD THE CROWNS PROPERLY, AND THE SCREWS WERE REMOVED. NO OTHER SCREWS WERE USED IN EXCHANGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24578130 ↗MalfunctionFeb 27, 2026Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24474027 ↗MalfunctionNov 21, 2025Fracture; Fracture
IT WAS REPORTED FRACTURE OF 2 DENTAL SCREWS WERE REMOVED. SCREWS PLACED ON (B)(6) 2022 AND REMOVED ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23615845 ↗MalfunctionOct 20, 2025Fracture; Fracture
IT WAS REPORTED THAT THE SCREW RETAINED CROWN HAS A DETACHMENT OF THE CERAMIC AND HAS BEEN SENT TO THE PROSTHETICS ON (B)(6) 2025. ON (B)(6) 2025 X-RAY WAS OK. WHEN SCREWING MANUALLY, THE SCREW FRACTURED. THE LOWER PART REMAINED INSIDE THE IMPLANT. PATIENT HAS BEEN SENT TO ANOTHER DOCTOR THAT IS SPECIALIST REMOVING THE FRACTURED SCREWS. APPOINTMENT SCHEDULED FOR (B)(6) 2025. TOOTH LOCATION 16. FRACTURE SCREW WAS ABLE TO BE REMOVED FROM THE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23334582 ↗MalfunctionAug 8, 2025Unintended Movement; Unintended Movement
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22747255 ↗MalfunctionJun 24, 2025Unintended Movement; Unintended Movement
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22320715 ↗MalfunctionJun 13, 2025Fracture; Fracture
THE DOCTOR REPORTS THAT THE DENTAL SCREWS LOCATED IN UNKNOWN BUCO-DENTAL POSITIONS FAILED BECAUSE THEY FRACTURED, SOME OF THEM FRACTURED BY THE HEAD. THE DOCTOR REPORTS THAT THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22201018 ↗MalfunctionJun 13, 2025Fracture; Fracture
THE DOCTOR REPORTS THAT THE DENTAL SCREWS LOCATED IN UNKNOWN BUCO-DENTAL POSITIONS FAILED BECAUSE THEY FRACTURED, SOME OF THEM FRACTURED BY THE HEAD. THE DOCTOR REPORTS THAT THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22200975 ↗MalfunctionJun 13, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22200959 ↗MalfunctionJun 13, 2025Fracture; Fracture
THE DOCTOR REPORTS THAT THE DENTAL SCREWS LOCATED IN UNKNOWN BUCO-DENTAL POSITIONS FAILED BECAUSE THEY FRACTURED, SOME OF THEM FRACTURED BY THE HEAD. THE DOCTOR REPORTS THAT THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22200944 ↗MalfunctionJun 6, 2025Unintended Movement; Unintended Movement
THE DOCTOR REPORTS THAT THE SCREW HAS LOOSENED. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER ITEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22156402 ↗MalfunctionApr 17, 2025Fracture; Fracture
THE DOCTOR REPORTS THAT THE SCREW FRACTURED AT THE HEAD AND WAS REMOVED. TOOTH POSITION: 26.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21853855 ↗MalfunctionJan 23, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21217778 ↗InjuryAug 9, 2024Fracture; Fracture
DOCTOR REPORTED FRACTURE OF PROSTHETIC SCREW AT TOOTH SITE 46 IN INTERNAL CONNECTION. IMPLANT HAD TO BE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19948037 ↗MalfunctionJul 29, 2024Unintended Movement; Unintended Movement
THE DOCTOR REPORTS THAT THE SCREW BECAME LOOSE. THE PROCEDURE WAS CONCLUDED WITH THE PLACEMENT OF ANOTHER SCREW. NO BONE TYPE OR DENTAL POSITION WAS REPORTED AS AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19850116 ↗MalfunctionMay 27, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19399973 ↗InjuryMay 8, 2024Fracture; Fracture
DOCTOR REPORTED SCREW FRACTURE AT TOOTH SITE 36 WHEN PLACING CROWN. IT WAS NOT POSSIBLE TO REMOVED FRACTURED FRAGMENT. IMPLANT WAS REMOVED AND A NEW ONE AND NEW CROWN WILL BE PLACED IN A FEW MONTHS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19270776 ↗
Other ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS devices
- CERTAIN® GOLD-TITE® IUNIHGZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS151 reports
- Nobel Biocare® 36662Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 recalls5 reports
- ATLANTIS® 35502Dentsply Ih, Inc. · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS66 reports
- ATLANTIS® 35502Dentsply Ih, Inc. · Abutment, implant, dental, endosseous54 reports
- Esthetic Abutment 36669Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall2 reports
- CERTAIN® BELLATEK® IEDAT5ZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall1 report
- Custom Abutments Final AbutmentsInstitut Straumann AG · Abutment, implant, dental, endosseous1 recall0 reports
- Legacy™ SMARTbase, Narrow, NE 8745-80NNEImplant Direct Sybron Manufacturing LLC · Abutment, Implant, Dental, Endosseous1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.