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	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
2026-01-07: integrum was informed that axor ii unit (b)(6) has fallen off from the abutment.No injury reported.The unit has not yet been received, hence no technical investigation performed.
Event or Problem Description
2026-01-07: integrum was informed that axor ii unit (b)(6) has fallen off from the abutment.No injury reported.Manufacturing investigation performed; no deviations were found.2026-02-24: technical investigation of unit (b)(6) performed.During the investigation the reported issue could be replicated; the top spring was tangled and worn causing insufficient grip.During the service the device was thoroughly cleaned, the top spring was replaced and the unit was functionally tested according to specification with approved results.A feedback report will be provided to the customer highlighting the importance of donning the axor ii according to the ifu and that the axor shall not be used if a stable connection cannot be achieved.

• 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: matilda svensson ; gemenskapens gata 9; molndal, 43153 ; SW 43153
• MDR Report Key: 24277827
• Report Number: 3011386779-2025-00256
• Device Sequence Number: 18287686
• Product Code: PJY
• UDI-Device Identifier: 07340152100634
• UDI-Public: 07340152100634
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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: 58777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2023
• 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