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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG TE, Ø 3.3 MM, RN, SLA 12.0 MM; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG TE, Ø 3.3 MM, RN, SLA 12.0 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 043.723S
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/07/2025
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2013 in ada 13.On (b)(6) 2025, fracture of the implant was verified.No product was returned to the manufacturer.There were no patient operative or post-operative complications reported.
 
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Brand Name
TE, Ø 3.3 MM, RN, SLA 12.0 MM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
SZ  04002
MDR Report Key23454493
Report Number0001222315-2025-003140
Device Sequence Number8345477
Product Code DZE
UDI-Device Identifier07630031701053
UDI-Public07630031701053
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 11/03/2025
Report Date (Section F) 10/07/2025
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 Expiration Date06/30/2017
Device Catalogue Number043.723S
Device Lot NumberEL137
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/03/2025
Event Location Other
Date Report to Manufacturer10/07/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/03/2025
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
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 SexMale
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