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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: Institut Straumann AG BLX ?4.0 RB, SLActive? 10mm, RXD; Endosseous Dental Implant
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Institut Straumann AG BLX ?4.0 RB, SLActive? 10mm, RXD; Endosseous Dental Implant Back to Search Results
Catalog Number 061.5310
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/30/2026
Type of Reportable Event Serious Injury
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Brand Name
BLX ?4.0 RB, SLActive? 10mm, RXD
Common Device Name
Endosseous Dental Implant
Manufacturer (Section D)
Institut Straumann AG
peter merian-weg 12
basel 04002
SZ  04002
MDR Report Key50823929
Report Number0001222315-2026-002866
Device Sequence Number13316557
Product Code DZE
UDI-Device Identifier07630031743527
UDI-Public07630031743527
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
Summary Report (Y/N)N
Device Implanted Year2026
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) 09/18/2026
Report Date (Section F) 09/18/2026
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 Number061.5310
Device Lot NumberWKHN7
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer08/25/2026
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/18/2026
Device Age7 MO
Event Location Other
Date Report to Manufacturer08/25/2026
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date09/18/2026
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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