MAUDE Adverse Event Report: INTEGRUM AB OPRA IMPLANT SYSTEM; FIXTURE BIOHELIX 19,5X80 MM

Model Number	1807
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	12/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On the (b)(6) 2021, integrum received an e-mail notification about a trauma incident for a patient treated at (b)(6) hospital.According to the information provided, the patient tripped and fell down a flight of stairs which caused a periprosthetic fracture of the opra implant.The fracture is through the top of the fixture and the treating surgeon is planning a revision surgery for the patient shortly. it has been reported that the patient is not compliant with the treatment protocol, however no information has been provided regarding in which way the patient is not compliant.The case will be followed up once more details on the revision treatment with treatment outcome are received, and device serial and lot numbers have been confirmed.

• Brand Name: OPRA IMPLANT SYSTEM
• Common Device Name: FIXTURE BIOHELIX 19,5X80 MM
• Manufacturer (Section D): INTEGRUM AB; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• Manufacturer (Section G): INTEGRUM AB; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• Manufacturer Contact: sofie ludvigsson ; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• MDR Report Key: 13280321
• Report Number: 3011386779-2022-00069
• Device Sequence Number: 17361659
• Product Code: PJY
• UDI-Device Identifier: 07340152100245
• UDI-Public: 07340152100245
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P190009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/14/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: 1807
• Device Catalogue Number: 1807
• 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: 12/17/2021
• Initial Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Age: 57 YR
• Patient Sex: Female