MAUDE Adverse Event Report: INTEGRUM OPRA IMPLANT SYSTEM; FIXTURE

Model Number	1800
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Fixture removal surgery due to suspected deep infection (not confirmed) or aseptic loosening.Pain when loading and osteolysis were reported as clinical signs.The procedure took place in sweden on (b)(6) 2025.
Event or Problem Description
Fixture removal surgery due to suspected deep infection (not confirmed) or aseptic loosening.Pain when loading and osteolysis were reported as clinical signs.The procedure took place in sweden on (b)(6) 2025.

• 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 Key: 22211227
• Report Number: 3011386779-2025-00237
• Device Sequence Number: 20872495
• Product Code: PJY
• UDI-Device Identifier: 07340152100177
• UDI-Public: 07340152100177
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P190009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• 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

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
• Device Expiration Date: 11/08/2024
• Device Model Number: 1800
• Device Catalogue Number: 1800
• Device Lot Number: 6077
• 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: 06/13/2025
• Initial Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2019
• 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 Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown