MAUDE Adverse Event Report: INTEGRUM AB OPRA IMPLANT SYSTEM; OPRA IMPLANT SYSTEM - ABUTMENT 12X87

Model Number	1820
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No deviation found in manufacturing records.Visual inspection of the replaced abutment confirms signs of uniform wear in the fixture-abutment press fit connection.The abutment screw fractured due to wear in the connection area.There is no need to further investigate the case since the root cause is known and confirmed as normal wear.The patient has been fitted with a new abutment and new abutment screw and is back on the system.
Event or Problem Description
Replacement surgery for the patient with the broken abutment screw.The patient was walking when the abutment screw fractured and the abutment fell out.The patient did not fall.The patient had the components replaced as a day surgery procedure.

• Brand Name: OPRA IMPLANT SYSTEM
• Common Device Name: OPRA IMPLANT SYSTEM - ABUTMENT 12X87
• Manufacturer (Section D): INTEGRUM AB; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• Manufacturer (Section G): INTEGRUM; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• Manufacturer Contact: justyna kolankowska ; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• MDR Report Key: 13692378
• Report Number: 3011386779-2022-00070
• Device Sequence Number: 20095296
• Product Code: PJY
• UDI-Device Identifier: 07340152100726
• UDI-Public: 07340152100726
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P190009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 03/08/2022

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: 5623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2016
• 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: Male