MAUDE Adverse Event Report: MEDTRONIC POWERED SURGICAL MEDTRONIC MIDAS REX; DUREGUARD

Model Number MEDT T9850/C0375

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 12/08/2015

Event Type  Injury  

Event Description

Midas rex footplate broke off during the craniotomy for tumor.Midas rex legend #8 is the specific drill involved.

• Brand Name: MEDTRONIC MIDAS REX
• Type of Device: DUREGUARD
• Manufacturer (Section D): MEDTRONIC POWERED SURGICAL; 4620 north beach street; fort worth TX 76137
• MDR Report Key: 5351022
• MDR Text Key: 35343526
• Report Number: MW5059034
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/31/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: MEDT T9850/C0375
• Device Lot Number: A0279
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Weight: 51