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

Model Number 1820

Device Problems Microbial Contamination of Device (2303); Appropriate Term/Code Not Available (3191)

Patient Problem Osteomyelitis (4533)

Event Date 09/08/2020

Event Type  Injury  

Manufacturer Narrative

The removed abutment and abutment screw were never returned.

Event 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
• Type of Device: OPRA IMPLANT SYSTEM - ABUTMENT AND ABUTMENT SCREW
• 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: sally skog ; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• MDR Report Key: 12165594
• MDR Text Key: 261449313
• Report Number: 3011386779-2021-00055
• Device Sequence Number: 1
• Product Code: PJY
• UDI-Device Identifier: 07340152100726
• UDI-Public: 07340152100726
• Combination Product (y/n): Y
• 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
• Type of Report: Initial
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1820
• Device Catalogue Number: 1820
• Device Lot Number: 9202/P 906485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization