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

Model Number 1820

Device Problem Mechanical Problem (1384)

Patient Problem Fluid Discharge (2686)

Event Date 04/25/2023

Event Type  Injury  

Manufacturer Narrative

The probable root cause for wear is overload considering the reported very high activity level of the patient, that this is the first abutment and abutment screw replacement and the lack of any other cause leading to wear.

Event Description

Abutment and abutment screw replacement surgery due wear in the press-fit area.Black secretion reported as clinical signs.Component replacement took place on (b)(6) 2023.

• Brand Name: OPRA IMPLANT SYSTEM
• Type of Device: ABUTMENT AND ABUTMENT SCREW
• Manufacturer (Section D): INTEGRUM AB; gemenskapens gata 9; mölndal, 431 5 3; SW 431 53
• Manufacturer (Section G): INTEGRUM AB; gemenskapens gata 9; mölndal, 431 5 3; SW 431 53
• Manufacturer Contact: matilda foung ; gemenskapens gata 9; mölndal, 431 5-3 ; SW 431 53
• MDR Report Key: 16938680
• MDR Text Key: 315292387
• Report Number: 3011386779-2023-00117
• 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: 05/16/2023

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 Operator: Lay User/Patient
• Device Model Number: 1820
• Device Catalogue Number: 1820
• Device Lot Number: 15446
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2023
• Initial Date FDA Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2021
• 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