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

Model Number	1288
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Fall (1848)
Type of Reportable Event	Malfunction
Event or Problem Description
2024-09-10 integrum received information about axor ii unit i6997 stating problem with rotation release and that the patient had fallen.An "initial" mir report was sent to swedish mpa 2024-09-24.During the technical investigation the reported issue could not be replicated.The rotation safety release mechanism was not too low.Additional information was received during the investigation, the fall resulted in a doctor´s visit and not hospitalization.A final (non-reportable) report ref.(b)(4) was sent to swedish mpa 2024-10-11.2025-01-17 integrum received information about axor ii unit i6997 stating problem with rotation release and that the patient had fallen.No health consequences or patient injury reported.The exact date of event is unknown.The unit has not been received at integrum hence, technical investigation has not yet been performed.The axor ii unit i6997 is in custody at vgr according to the (b)(4) report, 2025-03-14.Integrum has had several meetings and are in close contact with (b)(6).This event was concluded not reportable by integrum (internal case id #1870).During email conversation between the patient and the clinic, information was received that the patient does not use the device according to its "intended" purpose stated in the ifu e.G., working in the woods, "climbs" at construction builds, sometimes with water up to patient´s knees.It is likely that the rotation safety function releases due to that the patient challenge the device outside its intended use.2025-03-19 integrum received information (b)(6) regarding axor ii unit i6997.Integrum "responded" 2025-04-01 with a "initial" report and a detailed technical report response to swedish mpa report request 6.2.2-2025-023199 and notification ar 24812.2025-04-03 a visit meeting was held between integrum and (b)(6).The purpose with the meeting was to gain a better "understanding" of the patient´s problems and to try to find a solution going forward as the patients feedback is that the device releases too easy during use.It was decided that the axor ii i6997 will be returned to integrum for technical investigation.As information has been provided that the patient uses the device outside its intended use e.G., work in the woods, "climbs" at construction builds, sometimes with water up to the patient´s knees, the patient will be informed again about the importance to use the device according to the ifu.(b)(6) will inform the patient´s doctor about the meeting and the conclusion.Integrum requested that the doctor will be involved in upcoming meetings.Integrum will be available for support if needed.2025-04-03 integrum received the unit axor ii unit i6997 and performed technical investigation.During investigation the reported issue could not be replicated.The axors rotational release did not engage too easily i.E the release values were not too low.The root cause was set to that the patient does not use the device according to the ifu.The rotation and bending safety functions are there to protect the implant from excessive forces that could lead to harm.An final (non-reportable) report ref.(b)(4) was sent to swedish mpa 2025-04-16.2025-05-13 integrum received information on that the swedish mpa requested integrum to file a final incident report.2025-05-26 a final reportable incident report ref.(b)(4) was sent to the swedish mpa.

• 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: 22084130
• Report Number: 3011386779-2025-00233
• Device Sequence Number: 6906890
• Product Code: PJY
• UDI-Device Identifier: 07340152100634
• UDI-Public: 07340152100634
• Combination Product (Y/N): N
• 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
• Type of Report: Initial
• Report Date (Section B): 05/26/2025

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: 55711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 05/26/2025
• 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