MAUDE Adverse Event Report: INTEGRUM AB OPERA 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	12/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) 2025: integrum has been informed that axor ii unit (b)(6) has fallen off from the abutment.No health consequences or patient injury reported.Manufacturing investigation performed; batch documentation reviewed.No deviations found; the device has been manufactured according to specification.(b)(6) 2025: technical investigation of unit (b)(6) performed.During the investigation the functions were tested and components inspected.The reported issue could not be replicated.The clamps showed marks which indicates that the abutment may not have been fully inserted at some point.In addition, several components were damaged and incredibly dirty due to poor maintenance.During service, worn components were replaced.The device was thoroughly cleaned and functionally tested according to specification with approved results.
Event or Problem Description
(b)(6) 2025: integrum has been informed that axor ii unit(b)(4).Has fallen off from the abutment.No health consequences or patient injury reported.Manufacturing investigation performed, batch documentation reviewed.No deviations found, the device has been manufactured according to specification.(b)(6) 2025: technical investigation of unit (b)(4).Performed.During the investigation the functions were tested and components inspected.The reported issue could not be replicaded.The clamps showed marks which indicates that the abutment may not have been fully inserted at some point.In addition, several components were damaged and incredibly dirty due to poor maintenance.During service, worn components were replaced.The device was thoroughly cleaned and functionally tested according to specification with approved results.(b)(6) 2025: a feedback report sent to the customer highlight the importance of donning the axor ii according to the ifu to ensure a stable connection and prevent damage or wear to the clamps.The importance to move the leg/tap the foot on the floor, tighten further and check the attachment.As stated in the ifu, the device shall not be used if a stable connection cannot be achieved.The importance of cleaning the axor ii in accordance with the ifu and patient information.Failure to adhere to the instructions may affect the axor ii's function.Correct cleaning is also important prior to shipment for service.Failure to adhere to the instructions can compromise the safety of integrum staff.A reminder to send the device to integrum for annual service.

• Brand Name: OPERA 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: 21294177
• Report Number: 3011386779-2025-00216
• Device Sequence Number: 21143448
• Product Code: PJY
• UDI-Device Identifier: 07340152100634
• UDI-Public: 07340152100634
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 02/26/2025

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: 56381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 02/26/2025
• 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