MAUDE Adverse Event Report: INTEGRUM AB OPRA IMPLANT SYSTEM; OPRA IMPLANT SYSTEM - ABUTMENT AND ABUTMENT SCREW

Model Number	1820
Health Effect - Clinical Code	Osteomyelitis (4533)
Date of Event	09/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The removed abutment and abutment screw were never returned.
Event or Problem Description
2021-06-29: qa has become aware about an unreported event regarding deep infection.The sales rep at integrum inc.Has informed that the patient had an infection after the replacement of abutment (sn (b)(4), lot 9202) and abutment screw.The abutment/abutment screw were removed again and antibiotic beads were inserted.The new abutment and abutment screw were installed on (b)(6) 2020, when the infection was healed.Implants used in the final attempt at (b)(6) hospital are ref 1999 abutment screw lot 9312, and 1820 abutment 12x78 serial number (b)(4) lot# 9821.This is a femur bilateral + left transhumeral patient.The replaced abutment and ab.Screw were from the left femur side.

• Brand Name: OPRA IMPLANT SYSTEM
• Common Device Name: OPRA IMPLANT SYSTEM - ABUTMENT AND ABUTMENT SCREW
• Manufacturer (Section D): INTEGRUM AB; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• MDR Report Key: 12165594
• Report Number: 3011386779-2021-00055
• Device Sequence Number: 3782321
• Product Code: PJY
• UDI-Device Identifier: 07340152100726
• UDI-Public: 07340152100726
• Combination Product (Y/N): Y
• 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
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2021

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: No Information
• Device Expiration Date: 09/01/2024
• Device Model Number: 1820
• Device Catalogue Number: 1820
• Device Lot Number: 9202/P 906485
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization