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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRUM OPRA IMPLANT SYSTEM; FIXTURE
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INTEGRUM OPRA IMPLANT SYSTEM; FIXTURE Back to Search Results
Model Number 1804
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 05/09/2025
Type of Reportable Event Serious Injury
Event or Problem Description
Fixture removal surgery due to aseptic loosening.The procedure took place on (b)(6) 2025.
 
Additional Manufacturer Narrative
Fixture removal surgery due to aseptic loosening.The procedure took place on (b)(6) 2025.
 
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Brand Name
OPRA IMPLANT SYSTEM
Common Device Name
FIXTURE
Manufacturer (Section D)
INTEGRUM
SW 
Manufacturer Contact
matilda foung
gemenskapens gata 9
molndal, 43153
SW   43153
MDR Report Key22211226
Report Number3011386779-2025-00235
Device Sequence Number8158211
Product Code PJY
UDI-Device Identifier07340152100214
UDI-Public07340152100214
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P190009
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2024
Device Explanted Year2025
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source Health Professional
Initial Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date (Section B) 06/16/2025
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 Lay User/Patient
Device Expiration Date11/30/2024
Device Model Number1804
Device Catalogue Number1804
Device Lot Number16412
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/10/2025
Initial Report FDA Received Date06/16/2025
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured12/05/2022
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 Other;
Patient SexUnknown
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