MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK; CENTERING PIN

Device Problems Break (1069); Component Falling (1105)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/28/2016

Event Type  malfunction  

Event Description

When doing spine surgery, the instrument that was being inserted broke, all pieces were collected.

• Type of Device: CENTERING PIN
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK
• MDR Report Key: 5797875
• MDR Text Key: 49798441
• Report Number: MW5063418
• Device Sequence Number: 0
• Product Code: NEK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/12/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/12/2016
• Type of Device Usage: N
• Patient Sequence Number: 0