MAUDE Adverse Event Report: MEDICREA USA CORP. PASS TULIP; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/20/2020

Event Type  malfunction  

Event Description

Implant malfunction.Implant came apart unintentionally.Surgeon able to retrieve all pieces of item.

• Brand Name: PASS TULIP
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDICREA USA CORP.; 50 greene street 5th floor; new york NY 10013
• MDR Report Key: 9699420
• MDR Text Key: 178968732
• Report Number: 9699420
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20805 DA