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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG TE IMPL., 4.8MM WN, SLACTIVE 14MM; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG TE IMPL., 4.8MM WN, SLACTIVE 14MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number SLActive Titanium TL
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Unspecified Infection (1930); Swelling/ Edema (4577)
Date of Event 12/12/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2019 in ada 2.Details of surgery: 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.At the event the patient experienced: infection and swelling.No further patient complications were reported.
 
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Brand Name
TE IMPL., 4.8MM WN, SLACTIVE 14MM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
CH  04002
MDR Report Key10914049
Report Number0001222315-2020-15284
Device Sequence Number13741709
Product Code DZE
UDI-Device Identifier07630031716422
UDI-Public07630031716422
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K033984
Number of Events Summarized1
Summary Report (Y/N)Y
Device Implanted Year2019
Device Explanted Year2019
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 11/27/2020
Report Date (Section F) 11/03/2020
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 Date12/31/2016
Device Model NumberSLActive Titanium TL
Device Catalogue Number033.714S
Device Lot NumberCR629
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/27/2020
Device Age96 MO
Event Location Other
Date Report to Manufacturer11/03/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/03/2020
Initial Report FDA Received Date11/27/2020
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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