MAUDE Adverse Event Report: INTEGRUM OPRA IMPLANT SYSTEM - ABUTMENT SCREW, CENTRAL SCREW

Model Number 1999

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Implant Pain (4561)

Event Date 10/10/2022

Event Type  Injury  

Event Description

Central screw and abutment screw replacement after treatment of infection.No product wear or failure reported.

Manufacturer Narrative

No deviation was identified in the production nor sterilization records.

• Brand Name: OPRA IMPLANT SYSTEM - ABUTMENT SCREW, CENTRAL SCREW
• Type of Device: OPRA IMPLANT SYSTEM - ABUTMENT SCREW, CENTRAL SCREW
• Manufacturer (Section D): INTEGRUM; SW
• Manufacturer Contact: matilda foung ; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• MDR Report Key: 15754753
• MDR Text Key: 303264179
• Report Number: 3011386779-2022-00088
• Device Sequence Number: 1
• Product Code: PJY
• Combination Product (y/n): N
• 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: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/08/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: 1999
• Device Catalogue Number: 1999
• Device Lot Number: 13934
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2021
• 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