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

Model Number	1803
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Surgery for fixture removal from tibia due to fixture loosening and skeletal fracture.Pain when loading reported as clinical sign.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 (Section G): INTEGRUM AB; gemenskapens gata 9; molndal, 43153 ; SW 43153
• Manufacturer Contact: matilda svensson ; gemenskapens gata 9; molndal, 43153 ; SW 43153
• MDR Report Key: 24590460
• Report Number: 3011386779-2026-00264
• Device Sequence Number: 10114860
• Product Code: PJY
• UDI-Device Identifier: 07340152100207
• UDI-Public: 07340152100207
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P190009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/12/2026

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: 1803
• Device Lot Number: 13688
• 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: 02/25/2026
• Initial Report FDA Received Date: 03/13/2026
• 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