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

Model Number 1353

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2023

Event Type  Injury  

Event 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.

Manufacturer Narrative

A root cause is not possible to be confirmed.No product problem identified.

• Brand Name: OPRA IMPLANT SYSTEM
• Type of Device: 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
• MDR Text Key: 315375290
• Report Number: 3011386779-2023-00119
• Device Sequence Number: 1
• Product Code: PJY
• UDI-Device Identifier: 07340152100160
• UDI-Public: 07340152100160
• 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: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1353
• Device Catalogue Number: 1353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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