MAUDE Adverse Event Report: INTEGRUM AB OPRA 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

Integrum was informed that during late summer (exact incident date is unknown), the axor ii fell off (detached) from the abutment, causing the patient to drop the prosthetic leg while walking at work.The patient did not fall and was not harmed.The patient has since then felt unsafe, and the unit was therefore sent to integrum for technical investigation.Manufacturing investigation has been performed.Batch documentation reviewed, no deviations found.Manufacturing date: 2015-11-09 unit was last released after service 2019-10-07.Technical investigation has been performed.The user experiences the axor ii loosening during use.During inspection, the top components were found to be worn and damaged.During service, all top components were replaced.An early wear or corrosion in the device can be reduced by cleaning the device frequently as stated in the instruction for use.

• Brand Name: OPRA AXOR II
• Type of Device: OPRA AXOR II
• Manufacturer (Section D): INTEGRUM AB; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• MDR Report Key: 12674107
• MDR Text Key: 282219649
• Report Number: 3011386779-2021-00060
• Device Sequence Number: 1
• Product Code: PJY
• 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
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• 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: U77485-2-9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 75