MAUDE Adverse Event Report: Integrum AB OPRA Implant System; Fixture

Model Number	1804
Medical Device Problem Codes	Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	08/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Fixture removal surgery due to fixture loosening.The procedure took place on (b)(6), 2026.

• 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: 50515578
• Report Number: 3011386779-2026-00280
• Device Sequence Number: 9309685
• Product Code: PJY
• UDI-Device Identifier: 07340152100214
• UDI-Public: 07340152100214
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P190009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 08/31/2026

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: 1804
• Device Lot Number: P2219835
• 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: 08/17/2026
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown