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

Model Number	1288
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Fall (1848)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On oct.16 2025: integrum received information that a patient's axor ii (i9069) released in bending and rotation during use and caused the patient to fall.No injuries reported.The date of the events is unknown.Manufacturing investigation performed, batch documentation reviewed.No deviations found, the device has been manufactured according to specification, including functionally tested with pass result as part of final release.Oct.27 2025: technical investigation of unit i9069 performed.During the investigation the device functions were tested and components inspected.The reported issues could be replicated only for rotation release which had values below specification.The root cause could not be established.The bending release was within specification.During service, the unit was cleaned and the rotation release mechanism calibrated.The unit was functionally tested according to specification with approved results.

• 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: 23437406
• Report Number: 3011386779-2025-00255
• Device Sequence Number: 20989065
• Product Code: PJY
• UDI-Device Identifier: 07340152100634
• UDI-Public: 07340152100634
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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: Repair,Inspection
• Type of Report: Initial
• Report Date (Section B): 10/31/2025

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: 56855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2022
• 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