MAUDE Adverse Event Report: INTEGRUM AB OPRA IMPLANT SYSTEM; FIXTURE

Model Number	1800
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Implant Pain (4561)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Fixture removal surgery due to pain and fixture loosening.The procedure took place on (b)(6) 2025.

• 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 Key: 23425111
• Report Number: 3011386779-2025-00249
• Device Sequence Number: 13227406
• Product Code: PJY
• UDI-Device Identifier: 07340152100177
• UDI-Public: 07340152100177
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P190009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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
• Report Date (Section B): 10/30/2025

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 Number: 1800
• Device Catalogue Number: 1800
• Device Lot Number: 4567
• 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: 10/17/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2016
• 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: Hospitalization
• Patient Sex: Unknown