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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG S-IMPLANT Ø 3.3MM RN, SLACTIVE 8MM; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG S-IMPLANT Ø 3.3MM RN, SLACTIVE 8MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number SLActive Titanium TL
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 10/10/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2019 in the patient's mouth.Primary stability not achieved and implant surface not completely covered with bone.On (b)(6) 2019, 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
S-IMPLANT Ø 3.3MM RN, SLACTIVE 8MM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
CH  04002
MDR Report Key9624756
Report Number0009613348-2020-05459
Device Sequence Number585793
Product Code DZE
UDI-Device Identifier07630031714763
UDI-Public07630031714763
Combination Product (Y/N)N
Initial Reporter CountryCN
PMA/510(K) Number
K033984
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 01/23/2020
Report Date (Section F) 01/09/2020
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 Model NumberSLActive Titanium TL
Device Catalogue Number033.131S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/09/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/24/2020
Event Location Other
Date Report to Manufacturer01/09/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/09/2020
Initial Report FDA Received Date01/23/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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