MAUDE Adverse Event Report: INTEGRUM AB OPRA IMPLANT SYSTEM; AXOR II

Model Number 1288

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 07/07/2023

Event Type  malfunction  

Event Description

(b)(6) 2023: integrum received a request for a loaner unit together with information that the patient had fallen due axor ii i6556.No injuries reported.The cpo states that there is movement in the axor ii due to loose bolts.The unit has not yet been received at integrum for technical investigation.

Event Description

2023-07-07: integrum received a request for a loaner unit together with information that the patient had fallen due axor ii i6556.No injuries reported.The cpo states that there is movement in the axor ii due to loose bolts.The unit has not yet been received at integrum for technical investigation.Manufacturing investigation performed; batch documentation for axor ii i6556 reviewed (docreg 011 083-00).No deviations, however the batch was released with three concessions, none of which have any impact on the reported issue or the product safety and effectiveness.(b)(6) 2023: technical investigation of unit i6556 performed.During the investigation, no issue regarding the alignment nuts was noted, and the rotation release value was within specification.There are no indications that the patient fell due to a malfuntion in the axor ii.The unit was serviced and tested according to specification with approved results.

• Brand Name: OPRA IMPLANT SYSTEM
• Type of Device: AXOR II
• Manufacturer (Section D): INTEGRUM AB; gemenskapens gata 9; molndal, 43153 ; SW 43153
• Manufacturer Contact: matilda svensson ; gemenskapens gata 9; molndal, 43153 ; SW 43153
• MDR Report Key: 17360479
• MDR Text Key: 319718748
• Report Number: 3011386779-2023-00123
• 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: Inspection
• Type of Report: Initial,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 56106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2023
• Initial Date FDA Received: 07/20/2023
• Supplement Dates Manufacturer Received: 07/07/2023
• Supplement Dates FDA Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2021
• 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