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	Fall (1848)
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025: integrum received a report form stating that the axor ii i9815 had fallen off from the abutment.The patient fell which caused an internal bleeding in the stump and hospitalization.The exact date of the incident is unknown.Manufacturing investigation performed, the unit has been manufactured according to specification.The unit not yet received; hence no technical investigation has been performed yet.
Event or Problem Description
2025-04-24: integrum received a report form stating that the axor ii (b)(6) had fallen off from the abutment.The patient fell which caused an internal bleeding in the stump and hospitalization.The exact date of the incident is unknown.Manufacturing investigation performed, the unit has been manufactured according to specification.The unit not yet received, hence no technical investigation has been performed yet.2025-06-13: 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 device is within the manufacturers specifications and functions as designed.The unit showed signs of poor cleaning and the clamps had marks indicating that the abutment may not have been fully inserted at some point.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.

• 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: 21983920
• Report Number: 3011386779-2025-00231
• Device Sequence Number: 4263770
• 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: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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: 61893
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 06/16/2025
• 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: Hospitalization
• Patient Sex: Unknown