MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC SCREW EXTENDER; PEDICLE SCREW SPINAL SYSTEM ADOLESCENT IDIOPATHIC SCOLIOSIS

Model Number 7578302

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 12/27/2019

Event Type  malfunction  

Event Description

Pt went posterior thoracic decompression, t 8-10 instrumentation, fusion, during the surgery while using the medtronic screw extender, 2 pieces broke off the main body and were immediately recovered.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC SCREW EXTENDER
• Type of Device: PEDICLE SCREW SPINAL SYSTEM ADOLESCENT IDIOPATHIC SCOLIOSIS
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 9552546
• MDR Text Key: 173950054
• Report Number: MW5092025
• Device Sequence Number: 1
• Product Code: OSH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7578302
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1