BellaTek MHLASCRecalls & reported problems
ZimVie US Corp LLC · TSV Titanium ASC Screw · Class 2 · Implant
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00844868044789), received between Aug 30, 2021 and Jan 30, 2025 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Fracture” (6 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
- Fracture6
- Unintended Movement2
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 30, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21278048 ↗MalfunctionJan 30, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21277947 ↗MalfunctionJan 6, 2025Fracture; Fracture
IT WAS REPORTED THAT A SCREW FRACTURED IN THE PATIENT'S MOUTH AT TOOTH #19. REQUESTED SCREW REMOVAL TOOLS TO RETRIEVE THE BROKEN PORTION FROM THE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21078842 ↗MalfunctionSep 3, 2024Fracture; Fracture
IT WAS REPORTED THAT MHLASC SCREW FRACTURED IN THE PATIENT'S MOUTH. THE RESTORATIVE DENTIST HAS THE TOP PORTIONS TO RETURN. NOT SURE IF THERE ARE ANY BROKEN PORTIONS IN THE IMPLANT, AS THE GUM TISSUE HAS GROWN OVER THE AREA. PATIENT REFERRED BACK TO ORAL SURGEON THAT PLACED THE IMPLANT TO REMOVE BROKEN PORTION IF NECESSARY AND PLACE HEALING ABUTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20125551 ↗MalfunctionSep 3, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20125446 ↗MalfunctionJun 27, 2024Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT HAD A FRACTURED SCREW IN THE MOUTH. SCREW WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19627801 ↗MalfunctionSep 2, 2021Unintended Movement; Unintended Movement
THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12414068 ↗MalfunctionAug 30, 2021Unintended 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 12383539 ↗
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- 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
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.