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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
2025-02-27: integrum has been informed that axor ii unit (b)(6) has fallen off from the abutment.No further information is available yet and the unit has not yet been received at integrum.Manufacturing investigation performed; batch documentation reviewed.No deviations found; the device has been manufactured according to specification.Technical investigation has not yet been performed.
Event or Problem Description
On 2025-02-27: integrum has been informed that axor ii unit (b)(6) has fallen off from the abutment.No further information is available yet and the unit has not yet been received at integrum.Manufacturing investigation performed, batch documentation reviewed.No deviations found, the device has been manufactured according to specification.Technical investigation has not yet been performed.On 2025-03-26: video of donning/doffing and photos of the abutment received from the clinic.However, the received information is not efficent for performing technical investigation.Integrum has been in contact with the clinic several times but not yet received the unit.
Event or Problem Description
On 2025-02-27: integrum has been informed that axor ii unit i11085 has fallen off from the abutment.No further information is available yet and the unit has not yet been received at integrum.Manufacturing investigation performed, batch documentation reviewed.No deviations found, the device has been manufactured according to specification.Technical investigation has not yet been performed.On (b)(6) 2025: video of donning/doffing and photos of the abutment received from the clinic.However, the received information is not efficient for performing technical investigation.Integrum has been in contact with the clinic several times but not yet received the unit.On 2025-05-28: integrum received a report form and axor ii unit i11085 for technical investigation to be performed.On 2025-06-02: technical investigation performed.During the investigation the device functions were tested and components inspected.The reported issue could not be replicated.The clamps showed signs of wear indicating that the abutment may not have been fully inserted at some point.During service the clamps were replaced.The device was thoroughly cleaned and functionally tested according to specification 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.
Event or Problem Description
2025-02-27: integrum has been informed that axor ii unit i11085 has fallen off from the abutment.No further information is available yet and the unit has not yet been received at integrum.Manufacturing investigation performed, batch documentation reviewed.No deviations found, the device has been manufactured according to specification.Technical investigation has not yet been performed.2025-03-26: video of donning/doffing and photos of the abutment received from the clinic.However, the received information is not efficent for performing technical investigation.Integrum has been in contact with the clinic several times but not yet received the unit.2025-05-28: integrum received a report form and axor ii unit i11085 for technical investigation to be performed.

• 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: 21676780
• Report Number: 3011386779-2025-00224
• Device Sequence Number: 7693186
• Product Code: PJY
• UDI-Device Identifier: 07340152100634
• UDI-Public: 07340152100634
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup,Followup,Followup
• Report Date (Section B): 06/12/2025

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: 62353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 03/26/2025; 05/28/2025; 05/28/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 04/22/2025; 05/28/2025; 06/12/2025
• 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