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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 2025-03-05: integrum has been informed that axor ii unit (b)(6) has fallen off from the abutment.Manufacturing investigation performed, batch documentation reviewed.No deviations found, the device has been manufactured according to specification.On 2025-03-18.Technical investigation of unit (b)(6) performed.During the investigation the device functions were tested and components inspected.The reported issue could not be replicaded.The clamps were showing signs of wear indicating that the abutment may not have been fully inserted at some point.During the service the device was thoroughly cleaned and damaged components were replaced.Finally, the device 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.
Event or Problem Description
2025-03-05: integrum has been informed that axor ii unit (b)(6) has fallen off from the abutment.Manufacturing investigation performed; batch documentation reviewed.No deviations found; the device has been manufactured according to specification.2025-03-18.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 clamps were showing signs of wear indicating that the abutment may have not been fully inserted at some point.During the service the device was thoroughly cleaned and damaged components were replaced.Finally, the device 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.
Additional Manufacturer Narrative
2025-03-27: corrections made to h.Device manufacturers only, 6.Adverse event problem: changed code (e) and (f) due to no health consequences or patient injury has been reported.Added type of investigation code (10) and (4111).

• 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: 21699166
• Report Number: 3011386779-2025-00226
• Device Sequence Number: 15779977
• Product Code: PJY
• UDI-Device Identifier: 07340152100634
• UDI-Public: 07340152100634
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Remedial Action: Repair,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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: 03/03/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 03/27/2025
• 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