MAUDE Adverse Event Report: ULRICH GMBH & CO. KG NEON3; OC DRILL, FLEXIBLE, 4.0MM

Model Number CS 3951-04

Device Problems Mechanical Problem (1384); Improper or Incorrect Procedure or Method (2017)

Patient Problem Failure of Implant (1924)

Event Date 10/15/2021

Event Type  malfunction  

Event Description

The drill broke, and destroyed the backout protection of the oc plate (wire).Plate had to be removed and replaced.The drill was used at 90 degrees but a maximum of 45 degrees is allowed.

• Brand Name: NEON3
• Type of Device: OC DRILL, FLEXIBLE, 4.0MM
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, baden-wurttemberg 89081 ; GM 89081
• Manufacturer (Section G): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, baden-wurttemberg 89081 ; GM 89081
• Manufacturer Contact: andreas hilzenbecher ; buchbrunnenweg 12; ulm, baden-wurttemberg 89081 ; GM 89081
• MDR Report Key: 12787835
• MDR Text Key: 284379030
• Report Number: 9612420-2021-00013
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123717
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: CS 3951-04
• Device Catalogue Number: CS 3951-04
• Device Lot Number: U009323
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization