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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG BL, Ø 4.1 MM RC, SLACT. 10 MM, GUIDATA; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG BL, Ø 4.1 MM RC, SLACT. 10 MM, GUIDATA; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number SLActive Titanium BL
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 02/26/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Report late due to asr to individual reporting transition per fda letter dated june 28, 2019.
 
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2019 in the patient's mouth.On (b)(6) 2019, non-osseointegration was verified.No product was returned to the manufacturer.There were no reported patient injuries or complications.
 
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Brand Name
BL, Ø 4.1 MM RC, SLACT. 10 MM, GUIDATA
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
CH  04002
MDR Report Key9971844
Report Number0009613348-2020-24616
Device Sequence Number19531455
Product Code DZE
UDI-Device Identifier07630031706799
UDI-Public07630031706799
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
K090260
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) 04/16/2020
Report Date (Section F) 03/12/2020
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 Date04/30/2018
Device Model NumberSLActive Titanium BL
Device Catalogue Number021.4110G
Device Lot NumberFN518
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/17/2020
Device Age70 MO
Event Location Other
Date Report to Manufacturer03/12/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/12/2020
Initial Report FDA Received Date04/17/2020
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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