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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG S-IMPLANTAT Ø4.1MM RN, SLACTIVE 16MM; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG S-IMPLANTAT Ø4.1MM RN, SLACTIVE 16MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number SLActive Titanium TL
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Swelling (2091)
Date of Event 11/25/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2009 in fdi 32.On (b)(6) 2019, loss of osseointegration was verified.The device was forwarded to the manufacturer.At the event the patient experienced: pain, swelling and bleeding.No further patient complications were reported.
 
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Brand Name
S-IMPLANTAT Ø4.1MM RN, SLACTIVE 16MM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
CH  04002
MDR Report Key9668653
Report Number0009613348-2020-07588
Device Sequence Number501625
Product Code DZE
UDI-Device Identifier07630031714589
UDI-Public07630031714589
Combination Product (Y/N)N
Initial Reporter CountryDE
PMA/510(K) Number
K033984
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2009
Device Explanted Year2019
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 02/04/2020
Report Date (Section F) 01/21/2020
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 Expiration Date11/30/2013
Device Model NumberSLActive Titanium TL
Device Catalogue Number033.035S
Device Lot NumberP0633
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/05/2020
Device Age132 MO
Event Location Other
Date Report to Manufacturer01/21/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/21/2020
Initial Report FDA Received Date02/04/2020
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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