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 BL, Ø 4.1 MM RC, SLACT. 10 MM, GUIDED; 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 BL, Ø 4.1 MM RC, SLACT. 10 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 Codes Pain (1994); Tissue Damage (2104)
Date of Event 12/17/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2013 in ada 20.Details of surgery: ridge augmentation.On (b)(6) 2019, loss of osseointegration was verified.Patient presented with previous bone augmentation.The device was forwarded to the manufacturer.At the event the patient experienced: pain and mobility.No further patient complications were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BL, Ø 4.1 MM RC, SLACT. 10 MM, GUIDED
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
CH  04002
MDR Report Key9674583
Report Number0009613348-2020-07802
Device Sequence Number11484183
Product Code DZE
UDI-Device Identifier07630031706799
UDI-Public07630031706799
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
K090260
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2019
Reporter Type Manufacturer
Report Source foreign
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 02/05/2020
Report Date (Section F) 01/22/2020
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 Date12/31/2017
Device Model NumberSLActive Titanium BL
Device Catalogue Number021.4110G
Device Lot NumberFC182
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/06/2020
Device Age84 MO
Event Location Other
Date Report to Manufacturer01/22/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/22/2020
Initial Report FDA Received Date02/05/2020
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 Age62 YR
-
-