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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG SP Ø 4.8MM RN, SLACTIVE® 14MM, TIZR, NTP; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG SP Ø 4.8MM RN, SLACTIVE® 14MM, TIZR, NTP; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 033.594S
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 12/09/2024
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2024 in ada 29.On (b)(6) 2024, 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
SP Ø 4.8MM RN, SLACTIVE® 14MM, TIZR, NTP
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
SZ  04002
MDR Report Key21346304
Report Number0001222315-2025-000320
Device Sequence Number7740824
Product Code DZE
UDI-Device Identifier07630031716194
UDI-Public07630031716194
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2024
Device Explanted Year2024
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 02/10/2025
Report Date (Section F) 01/15/2025
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 Number033.594S
Device Lot NumberLFH80
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2025
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/10/2025
Device Age29 MO
Event Location Other
Date Report to Manufacturer01/15/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date02/10/2025
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 Age73 YR
Patient SexMale
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