MAUDE Adverse Event Report: MEDTRONICS CERVICAL SCREW

Lot Number A20213-138

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems Calcium Deposits/Calcification (1758); Unspecified Infection (1930); Pain (1994); Foreign Body In Patient (2687)

Event Date 03/27/2017

Event Type  Injury  

Event Description

In (b)(6), i had cervical spine surgery that included a fusion at c-4/ c-5.In (b)(6), i was having pain radiating from the neck and left arm.I went to a new surgeon, who x-rayed my neck.It was discovered that one of the screws had broken.I had no injuries that would cause this to happen.It required surgery on (b)(6) to repair the area.I then contracted an infection that caused another surgery to debride the area and remove all hardware that could be removed.The broken screw could not be removed because of calcification.

• Brand Name: CERVICAL SCREW
• Type of Device: CERVICAL SCREW
• Manufacturer (Section D): MEDTRONICS
• MDR Report Key: 7027558
• MDR Text Key: 91935423
• Report Number: MW5073304
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/10/2017

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
• Device Operator: No Information
• Device Expiration Date: 01/23/2019
• Device Lot Number: A20213-138
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: AMLODIPINE; ATORAVASTATIN; GLIMEPIRIDE.; LANTUS; LOSARTAN; MELOXICAM; MULTIVITAMIN. ; NEXIUM; OTC MEDS: ASPIRIN 81 MG; RX MEDS: METFORMIN; TAMSULOSIN
• Patient Outcome(s): Hospitalization
• Patient Weight: 100