MAUDE Adverse Event Report: INTEGRUM AB OPRA AXOR II

Model Number 1288

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2021

Event Type  malfunction  

Event Description

The patient experiences the axor falling off from the abutment.The cpo has also tried attaching the unit but he also experiences it releasing from the abutment.However at arrival to integrum, the unit was tested and was found within specification and worked as intended.The unit was tested with a 13,7mm abutment to simulate a worn abutment and it passed all the tests.A video showing the attachment function of the axor was taken and it was sent to customer.The video is highlighting that it is essential to tighten the axor to the abutment with relatively high force to ensure a proper attachment.

• Brand Name: OPRA AXOR II
• Type of Device: AXOR II
• Manufacturer (Section D): INTEGRUM AB; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• Manufacturer (Section G): INTEGRUM AB; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• Manufacturer Contact: sally skog ; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• MDR Report Key: 11494490
• MDR Text Key: 260238190
• Report Number: 3011386779-2021-00048
• Device Sequence Number: 1
• Product Code: PJY
• UDI-Device Identifier: 07340152100634
• UDI-Public: 07340152100634
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P190009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1288
• Device Catalogue Number: 1288
• Device Lot Number: 53242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 03/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other