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

Model Number	1288
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fall (1848)
Date of Event	07/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
2025-07-15: integrum received information about axor ii unit (b)(6) stating problem with rotation relese.The patient fell and hit his head on pavement.Manufacturing investigation performed, batch documentation reviewed.No deviations found, the device has been manufactured according to specification.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 rotation release value was within the specification.The device showed signs of poor maintenance.The unit has not been sent to integrum for annual service according to instructions in the ifu.The clamps were damaged and showed signs of improper donning.During the service the device was thoroughly cleaned, the clamps replaced, and the rotational release calibrated.Finally, it was functionally tested with approved results.Integrum has informed 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; gemenskapens gata 9; molndal, 43153 ; SW 43153
• Manufacturer Contact: susanne börjesson ; gemenskapens gata 9; molndal, 43153 ; SW 43153
• MDR Report Key: 22769818
• Report Number: 3011386779-2025-00240
• Device Sequence Number: 21226093
• Product Code: PJY
• UDI-Device Identifier: 07340152100634
• UDI-Public: 07340152100634
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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
• Remedial Action: Repair,Inspection
• Type of Report: Initial
• Report Date (Section B): 08/11/2025

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
• Device Model Number: 1288
• Device Lot Number: 61893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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