MAUDE Adverse Event Report: EMD EDOSZKOP MUSZER GYARTO ES KERESKEDELMI KFT. NEUROLINE DISPOSABLE CRANIAL PERFORATOR WITH HUDSON; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Repair request initiated for device with the report of doesn't work and the burr did not stop after cutting the bone.No patient impact reported.Repair request escalated to a product event due to reason for return.On further follow-up it was stated that the perforator belongs to "emd" brand and there was no allegation against medtronic attachment and motor.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: NEUROLINE DISPOSABLE CRANIAL PERFORATOR WITH HUDSON
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): EMD EDOSZKOP MUSZER GYARTO ES KERESKEDELMI KFT.
• MDR Report Key: 19042392
• MDR Text Key: 339489071
• Report Number: MW5153541
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1