MAUDE Adverse Event Report: INTEGRUM AB OPRA IMPLANT SYSTEM

Model Number	1820
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
2021-10-19: qa at integrum received an e-mail about an abutment replacement surgery for a transfemoral patient.The replacement is done due to suspected wear on the abutment head causing problems with connecting the axor ii.As per information, this is a bilateral amputee patient, and the replacement concerns the right amputation side.Report form as well as product in question has been requested once the surgery is performed.2021-10-27: report form specifying details behind the incident has been provided.As reported by the treating surgeon, this is a highly active patient, resulting in metal erosion/wear of the abutment head, with visible grooves on the square head present.The axor ii is falling off, due to amount of wear on the abutment head and the axor ii device cannot grip the abutment.According to the information from the sales rep at integrum, the surgery went according to plan.It was easy to remove the abutment with the extraction kit.The new abutment and abutment screw were placed and the patient is back on the system.2021-11-12: the replaced product has not been received at integrum so the further investigation cannot be performed.It has most likely been discarded at the hospital.Only a picture of patient's abutment before the replacement was sent.The attached picture shows indications of the wear on the abutment square head.However further investigation of the abutment and gripping mechanism of the axor ii cannot be performed without the products being returned to integrum, therefore the probable cause cannot be confirmed.Neither complaint nor service on the axor ii device has been requested by the treating team before nor after the abutment replacement.It has been communicated that the patient's axor ii has never been sent for service at integrum, but checked and cleaned by patient's prosthetist.The sales rep at integrum confirms that the patient is extremely active.The analysis of product records has been performed, no deviation found, refer to (b)(4).Since neither the replaced product nor axor ii device has been sent to integrum, the root cause cannot be confirmed.It is highly likely that patient's activity level impacts wear rate on the square head of the abutment.The product has been in use for about 1.5 year (implanted in (b)(6) 2020).The treating team took the decision to replace the component and the patient is now back on the system using the same axor ii as before the surgery.No additional investigation can be done unless the products are returned to integrum.

• Brand Name: OPRA IMPLANT SYSTEM
• Common Device Name: OPRA IMPLANT SYSTEM
• Manufacturer (Section D): INTEGRUM AB; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• Manufacturer (Section G): INTEGRUM AB; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• Manufacturer Contact: sofie ludvigsson ; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• MDR Report Key: 12821034
• Report Number: 3011386779-2021-00064
• Device Sequence Number: 20257911
• Product Code: PJY
• UDI-Device Identifier: 07340152100726
• UDI-Public: 07340152100726
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P190009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/15/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 1820
• Device Catalogue Number: 1820
• Device Lot Number: 7600 / P801191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Weight: 77 KG