MAUDE Adverse Event Report: INTEGRUM AB AXOR II

Model Number 1288

Device Problems Device Dislodged or Dislocated (2923); Device Fell (4014)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2020

Event Type  malfunction  

Event Description

Integrum (b)(4) received an e-mail from vp for prosthetics from integrum inc that a patient reports the axor falling of a minimum of 10 times in the past week.A loan unit has been sent to the patient in usa immediately.It is still not clear what serial number the unit has or if it has been sent back to integrum (b)(4).It is also unclear which health professional has reported the incident initially to integrum inc.An e-mail sent to vp in integrum inc to clarify and to follow up on more information regarding the unit (18th of january).

Event Description

Integrum ab received an e-mail from vp for prosthetics from integrum inc that a patient reports the axor falling of a minimum of 10 times in the past week.A loan unit has been sent to the patient in usa immediately.It is still not clear what serial number the unit has or if it has been sent back to integrum ab.It is also unclear which health professional has reported the incident initially to integrum inc.An e-mail sent to vp in integrum inc to clarify and to follow up on more information regarding the unit (18th of january).07/14/2021: integrum ab has been informed by representative from integrum inc, who has been in contact with the responsible prosthetist, that the device will not be returned to integrum for technical investigation.When checking the device, the "prosthetist" found that the unit was very dirty and needed to be cleaned.Once a thorough cleaning was performed he felt it did not need to be returned.The case will therefore be closed.

• Brand Name: AXOR II
• Type of Device: AXOR II
• Manufacturer (Section D): INTEGRUM AB; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• MDR Report Key: 11197267
• MDR Text Key: 228859476
• Report Number: 3011386779-2021-00043
• Device Sequence Number: 1
• Product Code: PJY
• UDI-Device Identifier: 07340152100634
• UDI-Public: 07340152100634
• Combination Product (y/n): N
• PMA/PMN Number: P190009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other