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

Model Number 1288

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 08/22/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023: integrum received information that axor ii unit (b)(6) has released in bending and causing a patient to fall.The patient sustained bruises but no major injuries.The unit has not yet been received for technical investigation.

Event Description

(b)(6) 2023: manufacturing investigation performed.- batch documentation reviewed and no deviations were identified.The unit was manufactured according to specification.Technical investigation performed.- during the investigation, the bending release was found out of specification (slightly low).- the patient has received a new unit.(b)(6) 2023: integrum received information that axor ii unit i7001 has released in bending and causing a patient to fall.The patient sustained bruises but no major injuries.

• Brand Name: OPRA IMPLANT SYSTEM
• Type of Device: AXOR II
• Manufacturer (Section D): INTEGRUM AB; gemenskapens gata 9; molndal, 431 5 3; SW 431 53
• Manufacturer (Section G): INTEGRUM AB; gemenskapens gata 9; molndal, 431 5 3; SW 431 53
• Manufacturer Contact: matilda foung ; gemenskapens gata 9; molndal, 431 5-3 ; SW 431 53
• MDR Report Key: 17743208
• MDR Text Key: 323355834
• Report Number: 3011386779-2023-00126
• 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: Replace
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1288
• Device Lot Number: 55711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2021
• 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