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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG SLACTIVE S Ø 3.3 MM RN 8 MM; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG SLACTIVE S Ø 3.3 MM RN 8 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number SLActive Titanium TL
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 03/29/2020
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2011 in fdi 21.On (b)(6) 2020, loss of osseointegration was verified.The device was forwarded to the manufacturer.At the event the patient experienced: mobility.No further patient complications were reported.
 
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Brand Name
SLACTIVE S Ø 3.3 MM RN 8 MM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
CH  04002
MDR Report Key9962691
Report Number0009613348-2020-24476
Device Sequence Number3293611
Product Code DZE
UDI-Device Identifier07630031714763
UDI-Public07630031714763
Combination Product (Y/N)N
Initial Reporter CountryJP
PMA/510(K) Number
K033984
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2020
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 04/15/2020
Report Date (Section F) 04/01/2020
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 Manufacturer04/01/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/15/2020
Event Location Other
Date Report to Manufacturer04/01/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/01/2020
Initial Report FDA Received Date04/15/2020
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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