MIS Multi Unit MA-S3480Recalls & reported problems
MIS Implants Technologies Ltd. · Multi unit abutment 3mm, int. hex., SP · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07290108998917), received between Apr 21, 2026 and May 1, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2026Fracture
THE CUSTOMER REPORTED THAT THE MULTI-UNIT ABUTMENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25054394 ↗InjuryApr 21, 2026Fracture
CUSTOMER REPORTED THAT UPON ARRIVAL FOR PROSTHESIS MAINTENANCE, BOTH STRAIGHT ABUTMENTS FRACTURED, LEAVING PART OF THE ABUTMENT INSIDE THE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24941124 ↗InjuryApr 21, 2026Fracture
CUSTOMER REPORTED THAT UPON ARRIVAL FOR PROSTHESIS MAINTENANCE, BOTH STRAIGHT ABUTMENTS FRACTURED, LEAVING PART OF THE ABUTMENT INSIDE THE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24941027 ↗
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- CERTAIN® IUNIHTZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS67 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
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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