MAUDE Adverse Event Report: INTEGRUM AB OPRA IMPLANT SYSTEM

Model Number	1820
Medical Device Problem Code	Unclear Information (4052)
Health Effect - Clinical Code	Fall (1848)
Date of Event	06/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
2021-06-23: qa at integrum has become aware about a patient scheduled for a surgery due to abutment fracture with bent abutment screw.The probable cause is trauma which has been communicated with sales rep at int inc., but no details had been specified.As per info provided via report form, the patient fell while walking upstairs with his prosthetic foot stepped on a chip sticking out from the ground.The patient fell on his abutment when fail safe activated.Integrum ab is following up via sales rep to get more information needed to understand the case.2021-07-07: the replaced product was sent back to iab on june 30th, yet not received yet.Technical analysis to be performed once the part is delivered.Manufacturing batch has been reviewed and no deviation related to the product was found.
Event or Problem Description
2021-06-23: qa at integrum has become aware about a patient scheduled for a surgery due to abutment fracture with bent abutment screw.The probable cause is trauma which has been communicated with sales rep at int inc., but no details had been specified.As per info provided via report form, the patient fell while walking upstairs with his prosthetic foot stepped on a chip sticking out from the ground.The patient fell on his abutment when fail safe activated.Integrum ab is following up via sales rep to get more information needed to understand the case.2021-07-07: the replaced product was sent back to iab on (b)(6), yet not received yet.Technical analysis to be performed once the part is delivered.Manufacturing batch has been reviewed and no deviation related to the product was found.2021-09-01: parts have been received at integrum.Visual inspection of the retrieved components indicate a sudden fracture.The abutment screw is bent and stuck inside the distal part of the abutment which suggest further suggest that the system has been subjected to high loads, fracturing the abutment and bending the abutment screw during the fall.The cause of the failure is known, and there is no need of further investigation.

• Brand Name: OPRA IMPLANT SYSTEM
• Common Device Name: OPRA IMPLANT SYSTEM
• Manufacturer (Section D): INTEGRUM AB; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• MDR Report Key: 12165590
• Report Number: 3011386779-2021-00053
• Device Sequence Number: 17089365
• Product Code: PJY
• UDI-Device Identifier: 07340152100726
• UDI-Public: 07340152100726
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P190009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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 Expiration Date: 06/01/2023
• Device Model Number: 1820
• Device Catalogue Number: 1820
• Device Lot Number: 7600/P804606
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 09/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other