MAUDE Adverse Event Report: INTEGRA PAIN MANAGEMENT INTEGRA CRANIAL ACCESS KIT; DRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL)

Model Number INSHITHRZN

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2023

Event Type  malfunction  

Event Description

Wobbly chuck.

• Brand Name: INTEGRA CRANIAL ACCESS KIT
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL)
• Manufacturer (Section D): INTEGRA PAIN MANAGEMENT; 3498 west 2400 south; #1050; west valley city UT 84119
• MDR Report Key: 18711018
• MDR Text Key: 335468698
• Report Number: 18711018
• Device Sequence Number: 1
• Product Code: HBG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INSHITHRZN
• Device Catalogue Number: INSHITHRZN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/11/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1