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

Model Number	1353
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
No product problem.Central screw replacement surgery due to flushing of a suspected infection.No clinical signs reported.Component replacement took place on (b)(6) 2023.
Additional Manufacturer Narrative
A root cause is not possible to be confirmed.No product problem identified.

• Brand Name: OPRA IMPLANT SYSTEM
• Common Device Name: CENTRAL 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: 16945652
• Report Number: 3011386779-2023-00119
• Device Sequence Number: 6376535
• Product Code: PJY
• UDI-Device Identifier: 07340152100160
• UDI-Public: 07340152100160
• 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 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): 05/17/2023

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: 1353
• Device Catalogue Number: 1353
• 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: 05/10/2023
• Initial Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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