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

Model Number	1820
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fluid Discharge (2686); Implant Pain (4561)
Date of Event	08/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The most probable root cause is overload considering the reported 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 fracture.
Event or Problem Description
Abutment and abutment screw replacement surgery due to fractured abutment.Black secretion and pain when loading were reported as clinical signs.Component replacement surgery took place on (b)(6) 2023.

• Brand Name: OPRA IMPLANT SYSTEM
• Common Device Name: ABUTMENT
• Manufacturer (Section D): INTEGRUM AB; gemenskapens gata 9; molndal, 431 5 3; SW 431 53
• Manufacturer (Section G): INTEGRUM AB; gemenskapens gata 9; molndal, 431 5 3; SW 431 53
• Manufacturer Contact: matilda foung ; gemenskapens gata 9; molndal, 431 5-3 ; SW 431 53
• MDR Report Key: 17798041
• Report Number: 3011386779-2023-00128
• Device Sequence Number: 7601464
• Product Code: PJY
• UDI-Device Identifier: 07340152100726
• UDI-Public: 07340152100726
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P190009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/22/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 1820
• Device Catalogue Number: 1820
• Device Lot Number: 13542
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown