Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG TE-IMPLANT, 4.1MM, WN, SLACTIVE, 10.0MM; ENDOSSEOUS DENTAL IMPLANT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INSTITUT STRAUMANN AG TE-IMPLANT, 4.1MM, WN, SLACTIVE, 10.0MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number SLActive Titanium TL
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/16/2021
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2020 in ada 19.On (b)(6) 2021, non-osseointegration was verified.The device was forwarded to the manufacturer.There were no reported patient injuries or complications.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TE-IMPLANT, 4.1MM, WN, SLACTIVE, 10.0MM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
SZ  04002
MDR Report Key11857138
Report Number0001222315-2021-08365
Device Sequence Number16918791
Product Code DZE
UDI-Device Identifier07630031727589
UDI-Public07630031727589
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
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) 05/20/2021
Report Date (Section F) 04/26/2021
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 Expiration Date07/17/2024
Device Model NumberSLActive Titanium TL
Device Catalogue Number80494S
Device Lot NumberXP450
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2021
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/20/2021
Device Age20 MO
Event Location Other
Date Report to Manufacturer04/26/2021
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date05/20/2021
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 Age26 YR
-
-