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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRUM AB OPRA IMPLANT SYSTEM; FIXTURE
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INTEGRUM AB OPRA IMPLANT SYSTEM; FIXTURE Back to Search Results
Model Number 1804
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Unspecified Infection (1930); Inadequate Osseointegration (2646); Implant Pain (4561)
Date of Event 10/27/2025
Type of Reportable Event Serious Injury
Event or Problem Description
Fixture removal surgery due to deep infection and aseptic loosening.Pain was reported as clinical signs.The procedure took place in (b)(6) 2025.
 
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Brand Name
OPRA IMPLANT SYSTEM
Common Device Name
FIXTURE
Manufacturer (Section D)
INTEGRUM AB
gemenskapens gata 9
molndal, 43153
SW  43153
Manufacturer Contact
matilda svensson
gemenskapens gata 9
molndal, 43153
SW   43153
MDR Report Key23485516
Report Number3011386779-2025-00250
Device Sequence Number10558730
Product Code PJY
UDI-Device Identifier07340152100214
UDI-Public07340152100214
Combination Product (Y/N)N
Initial Reporter StateNH
Initial Reporter CountryUS
PMA/510(K) Number
P190009
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2023
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) 11/06/2025
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 Model Number1804
Device Catalogue Number1804
Device Lot Number15606
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 10/27/2025
Initial Report FDA Received Date11/06/2025
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured06/14/2022
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 Required Intervention;
Patient SexUnknown
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