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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG S-IMPLANTAT Ø 4.8MM RN, SLACTIVE 12MM; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG S-IMPLANTAT Ø 4.8MM RN, SLACTIVE 12MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number SLActive Titanium TL
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code Pain (1994)
Date of Event 02/28/2020
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2009 in fdi 46.On (b)(6) 2020, loss of osseointegration was verified.Patient presented with bruxism.The device was forwarded to the manufacturer.At the event the patient experienced: pain.No further patient complications were reported.
 
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Brand Name
S-IMPLANTAT Ø 4.8MM RN, SLACTIVE 12MM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
CH  04002
MDR Report Key9862072
Report Number0009613348-2020-19177
Device Sequence Number19485787
Product Code DZE
UDI-Device Identifier07630031714886
UDI-Public07630031714886
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K033984
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2009
Device Explanted Year2020
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 03/20/2020
Report Date (Section F) 03/06/2020
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 Date02/28/2013
Device Model NumberSLActive Titanium TL
Device Catalogue Number033.233S
Device Lot NumberJ3858
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/20/2020
Device Age144 MO
Event Location Other
Date Report to Manufacturer03/06/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/06/2020
Initial Report FDA Received Date03/20/2020
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;
Patient Age40 YR
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