MAUDE Adverse Event Report: INTEGRUM AB AXOR II

Model Number 1288

Device Problem Device Dislodged or Dislocated (2923)

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

Event Type  malfunction  

Event Description

Axor ii fell off as the patient was walking.Patient had been wearing the unit for an hour before it released.The patient did not fall or get hurt when prosthesis fell off.It had happened 2 times prior but within first 2 steps.The device was returned to integrum for investigation and service.During investigation, the clamps were found worn, causing issues with the attachment function.During service, top spring and clamps were replaced to address the attachment issues.The device has been in use without service and maintenance for more than 3 years, therefore the case can be considered to be normal wear.According to the instructions for use, the device should be checked for signs of wear annually.

• Brand Name: 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: sofie ludvigsson ; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• MDR Report Key: 12495961
• MDR Text Key: 272274295
• Report Number: 3011386779-2021-00058
• Device Sequence Number: 1
• Product Code: PJY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Repair
• Type of Report: Initial
• Report Date: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• 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: U87002-3-28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other