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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOBEL BIOCARE AB GÖTEBORG ZYGOMA IMPLANT RP 40MM; ENDOSSEOUS DENTAL IMPLANT
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NOBEL BIOCARE AB GÖTEBORG ZYGOMA IMPLANT RP 40MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 28864
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 11/05/2024
Type of Reportable Event Serious Injury
Event or Problem Description
Loss of osseointegration.
 
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Brand Name
ZYGOMA IMPLANT RP 40MM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
NOBEL BIOCARE AB GÖTEBORG
bohusgatan 15
göteborg 41139
SW  41139
MDR Report Key21184676
Report Number2027971-2025-033072
Device Sequence Number14524728
Product Code DZE
UDI-Device Identifier07332747025187
UDI-Public(01)07332747025187(10)12101073(17)221202
Combination Product (Y/N)N
Initial Reporter CountryFR
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2024
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section F) 01/17/2025
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 Date12/02/2022
Device Catalogue Number28864
Device Lot Number12101073
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2025
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/10/2025
Event Location Outpatient Treatment Facility
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/17/2025
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device A
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age79 YR
Patient SexMale
Date Report Sent to FDA01/17/2025
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