MAUDE Adverse Event Report: INTEGRUM AB OPRA IMPLANT SYSTEM; 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 04/25/2023

Event Type  malfunction  

Event Description

2023-05-23: unit (b)(6) was returned to integrum with a report form stating that the axor ii has detached while walking several times.The reported date of experience is (b)(6) 2023, however integrum was not informed prior to receiving the unit.No fall or injury reported.2023-06-16: technical investigation performed, the reported issue could not be replicated, the unit passed the gripping test.It was however noted that the clamps were mounted in the wrong sequence.Manufacturing investigation performed; assembly and test record for axor ii (b)(6) reviewed, no deviations were found.It cannot be excluded that the sequence may have been altered during use and/or cleaning of the device.No final root cause could be determined.During the service, the clamps were replaced.The unit has been serviced and now functions according to specification.A feedback report has been provided to the cpo/patient highlighting the importance of donning the axor ii according to the ifu, and that the axor ii should not be used if a stable connection cannot be achieved.

• Brand Name: OPRA IMPLANT SYSTEM
• Type of Device: AXOR II
• Manufacturer (Section D): INTEGRUM AB; gemenskapens gata 9; molndal, 43153 ; SW 43153
• Manufacturer (Section G): INTEGRUM; SW
• Manufacturer Contact: matilda svensson ; gemenskapens gata 9; molndal, 43153 ; SW 43153
• MDR Report Key: 17170607
• MDR Text Key: 318306466
• Report Number: 3011386779-2023-00120
• Device Sequence Number: 1
• Product Code: PJY
• UDI-Device Identifier: 07340152100634
• UDI-Public: 07340152100634
• 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: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1288
• Device Catalogue Number: 1288
• Device Lot Number: 58768
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2023
• Initial Date FDA Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2022
• 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