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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG BL, 4.8 MM RC, SLACT. 12 MM, GUIDED; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG BL, 4.8 MM RC, SLACT. 12 MM, GUIDED; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number SLActive Titanium BL
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/02/2021
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2013 in ada 19.On (b)(6) 2021, loss of osseointegration was verified.The device was forwarded to the manufacturer.There were no patient operative or post-operative complications reported.
 
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Brand Name
BL, 4.8 MM RC, SLACT. 12 MM, GUIDED
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
SZ  04002
MDR Report Key11833566
Report Number0001222315-2021-08057
Device Sequence Number4129260
Product Code DZE
UDI-Device Identifier07630031707222
UDI-Public07630031707222
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 05/17/2021
Report Date (Section F) 04/22/2021
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 BL
Device Catalogue Number021.6112G
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2021
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/17/2021
Event Location Other
Date Report to Manufacturer04/22/2021
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date05/17/2021
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 Age45 YR
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