MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRUMPF SWIVEL ADAPTER; HOLDER, HEAD, RADIOGRAPHIC

Model Number 1317786

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 03/30/2022

Event Type  malfunction  

Event Description

Had to reposition and redrape the patient twice prior to surgery due to malfunctioning mayfield equipment.Fda safety report id# (b)(4).

• Brand Name: TRUMPF SWIVEL ADAPTER
• Type of Device: HOLDER, HEAD, RADIOGRAPHIC
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
• MDR Report Key: 14407883
• MDR Text Key: 291825987
• Report Number: MW5109693
• Device Sequence Number: 1
• Product Code: KXJ
• 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: 05/11/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1317786
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male