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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG BL,Ø4.1MM RC, SLACT.12MM,ROXOLID,GUIDED; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG BL,Ø4.1MM RC, SLACT.12MM,ROXOLID,GUIDED; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 021.4312G
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 12/04/2025
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2025 in ada 11.On (b)(6) 2025, non-osseointegration was verified.The device was forwarded to the manufacturer.There were no reported patient injuries or complications.
 
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Brand Name
BL,Ø4.1MM RC, SLACT.12MM,ROXOLID,GUIDED
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
SZ  04002
MDR Report Key24041007
Report Number0001222315-2026-000135
Device Sequence Number10388167
Product Code DZE
UDI-Device Identifier07630031706881
UDI-Public07630031706881
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2025
Device Explanted Year2025
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 01/12/2026
Report Date (Section F) 12/18/2025
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 Catalogue Number021.4312G
Device Lot NumberMJF36
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2025
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/12/2026
Device Age41 MO
Event Location Other
Date Report to Manufacturer12/18/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/12/2026
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 SexMale
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