MAUDE Adverse Event Report: INTEGRUM AB OPRA IMPLANT SYSTEM; AXOR II

Model Number	1288
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Fall (1848)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Oct.17th, 2025: integrum received unit (b)(6) with a report form stating that the axor ii has loosened from the abutment causing the patient to fall multiple times.No injuries reported.The date of event is unknown.Manufacturing investigation performed, the unit has been manufactured according to specification.Nov.13th, 2025: technical investigation of unit (b)(6) performed.During the investigation the device functions were tested and components inspected.The reported issue could not be replicated; the device passed the manufacturer's tests related to gripping function.The guide screws discovered to have loctite failure; however, the screws were not backed out to cause any obstruction on functionality of device.The root cause of the reported issue could not be established.During service loctite was reapplied, the device was thoroughly cleaned and functionally tested according to specification with approved results.Integrum will inform the clinic on the importance of donning the axor ii according to the ifu to ensure a stable connection, and that the device shall not be used if a stable connection cannot be achieved.

• Brand Name: OPRA IMPLANT SYSTEM
• Common Device Name: AXOR II
• 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: 23554978
• Report Number: 3011386779-2025-00251
• Device Sequence Number: 10081530
• Product Code: PJY
• UDI-Device Identifier: 07340152100634
• UDI-Public: 07340152100634
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P190009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 11/14/2025

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: 1288
• Device Lot Number: 65092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2025
• 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: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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