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 SP, 3.3 MM, NN, SLA 14.0 MM; 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 SP, 3.3 MM, NN, SLA 14.0 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number SLA Titanium TL
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/13/2021
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2011 in the patient's mouth.On (b)(6) 2021, fracture of the implant was verified.The device was forwarded to the manufacturer.There were no patient operative or post-operative complications reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SP, 3.3 MM, NN, SLA 14.0 MM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
SZ  04002
MDR Report Key11878605
Report Number0001222315-2021-08451
Device Sequence Number3588913
Product Code DZE
UDI-Device Identifier07630031718303
UDI-Public07630031718303
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
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) 05/25/2021
Report Date (Section F) 04/29/2021
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 Date05/31/2011
Device Model NumberSLA Titanium TL
Device Catalogue Number042.933S
Device Lot NumberC0995
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2021
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/25/2021
Device Age176 MO
Event Location Other
Date Report to Manufacturer04/29/2021
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date05/25/2021
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 Age53 YR
-
-