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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTITUT STRAUMANN AG CIM Ø4.1MM RD, ZLA 14MM, AH5.5MM, ZRO2; ENDOSSEOUS DENTAL IMPLANT
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INSTITUT STRAUMANN AG CIM Ø4.1MM RD, ZLA 14MM, AH5.5MM, ZRO2; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 031.034S
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code Fibrosis (3167)
Date of Event 12/04/2024
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2024 in ada 12.On (b)(6) 2024, loss of osseointegration was verified.The device was forwarded to the manufacturer.At the event the patient experienced: mobility.No further patient complications were reported.
 
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Brand Name
CIM Ø4.1MM RD, ZLA 14MM, AH5.5MM, ZRO2
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
INSTITUT STRAUMANN AG
peter merian-weg 12
basel 04002
SZ  04002
MDR Report Key21082368
Report Number0001222315-2025-000060
Device Sequence Number8386237
Product Code DZE
UDI-Device Identifier07630031714015
UDI-Public07630031714015
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2024
Device Explanted Year2024
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 01/06/2025
Report Date (Section F) 12/13/2024
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 Catalogue Number031.034S
Device Lot NumberTWJ28
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2024
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/06/2025
Device Age19 MO
Event Location Other
Date Report to Manufacturer12/13/2024
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/06/2025
Was Device Evaluated by Manufacturer? (Y/N) Yes
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age34 YR
Patient SexMale
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