MAUDE Adverse Event Report: INTEGRUM OPRA IMPLANT SYSTEM; ABUTMENT

Model Number 2569

Device Problems Mechanical Problem (1384); Microbial Contamination of Device (2303)

Patient Problem Implant Pain (4561)

Event Date 03/14/2023

Event Type  Injury  

Event Description

Abutment, abutment screw and central screw replacement surgery for a patient due to deep infection and wear in the press-fit area.Pain when loading was reported.Component replacement took place on (b)(6) 2023.

Manufacturer Narrative

The most probable root cause for the mechanical wear is overload considering the reported high activity of the patient, and the lack of any other cause leading to press-fit wear.

• Brand Name: OPRA IMPLANT SYSTEM
• Type of Device: ABUTMENT
• Manufacturer (Section D): INTEGRUM; SW
• Manufacturer Contact: matilda foung ; molndal, ; SW
• MDR Report Key: 16713910
• MDR Text Key: 313036823
• Report Number: 3011386779-2023-00105
• 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: 04/11/2023

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 Model Number: 2569
• Device Lot Number: 1523-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2023
• Initial Date FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sex: Male