MAUDE Adverse Event Report: INTEGRUM AB OPRA IMPLANT SYSTEM; OPRA IMPLANT SYSTEM - ABUTMENT 12X78

Model Number	1820
Medical Device Problem Codes	Mechanical Problem (1384); Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection of the replaced components confirms signs of wear in the fixture-abutment press fit connection.The root cause is wear due to overload considering the reported high activity of the patient, that this is the first abutment replacement after s2 surgery and the lack of any other cause leading to wear issues.The new abutment and abutment screw were installed and the patient is back on the system.
Event or Problem Description
Abutment and abutment screw replacement surgery for a patient due to press fit wear that resulted in black secretion out of the abutment exit site and loosening with no soft tissue complication.The patient had the components replaced as a day surgery procedure.

• Brand Name: OPRA IMPLANT SYSTEM
• Common Device Name: OPRA IMPLANT SYSTEM - ABUTMENT 12X78
• 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: justyna kolankowska ; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• MDR Report Key: 14344606
• Report Number: 3011386779-2022-00076
• Device Sequence Number: 20397336
• 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: 2018
• Device Explanted Year: 2022
• 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): 05/09/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2017
• 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: Hospitalization
• Patient Sex: Unknown
• Patient Weight: 68 KG