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	08/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Sept.26th, 2025: integrum received unit i9130 with a report form stating that the axor ii has detached from the abutment causing the patient to fall multiple times, and that the patient sustained injuries to the eye socket, finger and hips and had to visit the er.Integrum has not received information regarding the specific injuries, i.E.The outcome of the er visit, hence the coding serious injury is a presumtion based on available information.Manufacturing investigation performed, the unit has been manufactured according to specification.Oct.10th, 2025: technical investigation of unit i9130 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.The clamps had some minor marks indicating that the abutment may not have been fully inserted at some point during use, however the root cause of the reported issue could not be established.During service, the clamps were replaced, 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 prevent damage or wear to the clamps.As stated in the ifu, 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: 23366232
• Report Number: 3011386779-2025-00246
• Device Sequence Number: 8916169
• Product Code: PJY
• UDI-Device Identifier: 07340152100634
• UDI-Public: 07340152100634
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 10/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1288
• Device Lot Number: 58767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2022
• 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