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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG BLX Ø4.5 RB, SLA® 16MM, RXD; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG BLX Ø4.5 RB, SLA® 16MM, RXD; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 061.6516
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 12/24/2025
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2025 in the patient's mouth.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
BLX Ø4.5 RB, SLA® 16MM, RXD
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
SZ  04002
MDR Report Key24897703
Report Number0001222315-2026-001123
Device Sequence Number18302789
Product Code DZE
UDI-Device Identifier07630031743695
UDI-Public07630031743695
Combination Product (Y/N)N
Initial Reporter StateGA
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) 04/16/2026
Report Date (Section F) 03/23/2026
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 Number061.6516
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2026
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/16/2026
Event Location Other
Date Report to Manufacturer03/23/2026
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date04/16/2026
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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