Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: Institut Straumann AG CI ?4.1mm RD, ZLA 10mm, ZrO2; Endosseous Dental Implant
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

Institut Straumann AG CI ?4.1mm RD, ZLA 10mm, ZrO2; Endosseous Dental Implant Back to Search Results
Catalog Number 032.001S
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code Fibrosis (3167)
Date of Event 06/22/2026
Type of Reportable Event Serious Injury
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CI ?4.1mm RD, ZLA 10mm, ZrO2
Common Device Name
Endosseous Dental Implant
Manufacturer (Section D)
Institut Straumann AG
peter merian-weg 12
basel 04002
SZ  04002
MDR Report Key50653105
Report Number0001222315-2026-002743
Device Sequence Number21204434
Product Code DZE
UDI-Device Identifier07630031714282
UDI-Public07630031714282
Combination Product (Y/N)N
Initial Reporter StateAK
Initial Reporter CountryUS
Summary Report (Y/N)N
Device Implanted Year2024
Device Explanted Year2026
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 09/07/2026
Report Date (Section F) 09/07/2026
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Catalogue Number032.001S
Device Lot NumberFYY17
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer08/14/2026
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/07/2026
Device Age53 MO
Event Location Other
Date Report to Manufacturer08/14/2026
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date09/07/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age68 YR
Patient SexMale
-
-