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 CIM D3.3MM ND, ZLA 14MM, AH4MM, ZRO2; 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 CIM D3.3MM ND, ZLA 14MM, AH4MM, ZRO2; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 031.004S
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Increased Sensitivity (2065); Tissue Damage (2104)
Date of Event 06/14/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2019 in fdi 22.Details of surgery: implant surface not completely covered with bone and ridge augmentation.On (b)(6) 2019 non-osseointegration was verified.The device was forwarded to the manufacturer.At the event the patient experienced: mobility and increased sensitivity.No further patient complications were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CIM D3.3MM ND, ZLA 14MM, AH4MM, ZRO2
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
CH  04002
MDR Report Key9419960
Report Number0009613348-2019-42958
Device Sequence Number2491487
Product Code DZE
UDI-Device Identifier07630031713810
UDI-Public07630031713810
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K171769
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) 12/05/2019
Report Date (Section F) 07/11/2019
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 Date01/24/2024
Device Catalogue Number031.004S
Device Lot NumberTW598
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/11/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/06/2019
Device Age5 MO
Event Location Other
Date Report to Manufacturer07/11/2019
Initial Date Received by Manufacturer 07/11/2019
Initial Report FDA Received Date12/05/2019
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 Age38 YR
-
-