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 Date 07/08/2021

Event Type  malfunction  

Event Description

Axor ii dislodged while the patient was walking.The patient did not fall.This was reported in an adverse event form as the patient is included in a pilot study ((b)(4)).Integrum was informed about the case on (b)(6) 2021.The unit has not been returned to integrum for technical investigation.The patient has reported that she is uncertain that she had optimally tightened the device prior to the dislodgement.The cpo has reviewed the instructions for use together with the patient, and has assessed that this should avoid future recurrence.

• 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: 12173001
• MDR Text Key: 261705944
• Report Number: 3011386779-2021-00056
• 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: study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1288
• Device Catalogue Number: 1288
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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