MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC MIDAS REX TAC-125; MIDAS REX T12

Model Number MIDAS REX T12

Device Problem Break (1069)

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

Event Date 09/27/2016

Event Type  Injury  

Event Description

During discectomy 2 tac-125 electric drill bits broke during use outside of the surgical site.All pieces retrieved.Diagnosis or reason for use: c4-6 laminectomy, disc anterior, cervical w/fusion.Event abated after use stopped or dose reduced: yes.

• Brand Name: MEDTRONIC MIDAS REX TAC-125
• Type of Device: MIDAS REX T12
• Manufacturer (Section D): MEDTRONIC; fort worth TX 76137
• MDR Report Key: 6002964
• MDR Text Key: 56800023
• Report Number: MW5065219
• Device Sequence Number: 1
• Product Code: HBB
• Reporter Country Code: US
• 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: 10/03/2016
• 2 Devices were Involved in the Event: 1 2

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
• Device Model Number: MIDAS REX T12
• Device Catalogue Number: T12MH25
• Device Lot Number: H5257213
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NONE. PRODUCT REMOVED FROM FIELD AND USE
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR