MAUDE Adverse Event Report: KAVO DENTAL GMBH INTRA LUX HEAD 68 LH; DENTAL HANDPIECE ATTACHEMENT

Model Number 68 LH

Device Problem Use of Device Problem (1670)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/27/2021

Event Type  malfunction  

Manufacturer Narrative

Within the evaluation of the handpiece head there was only found some standard wearing regarding the ball bearings.Normal wear for a head manufactured in 2003.But the chuck system was in a good condition.Retention forces completely within specifications.So the complaint with low retention force or lost bur was not comprehensible.Therefore we have to assume that the used bur or tooling was not suitable and not released for our standard chuck system.Unfortunately the dentist does not provide the requested bur or some similar burs to verify this assumption.Ifu contains already following warnings: release of the medical device during treatment.If the head is not properly locked in place, it can fall out during treatment.Do not mount or remove the head while rotating.Before each treatment, check if the head is firmly seated and if the clamping ring is tight.Note: only use carbide cutters or diamond drill bits that respond to iso 1797-1 type 1, are made of steel or hardmetal and meet the following criteria: shaft diameter: 2.334 to 2.35 mm.Overall length: max.22 mm.

Event Description

Cavity was drilled with a rose drill.The drill detached from the handpiece and was swallowed by the patient.Dentist tried to take out the drill from the throat but it couldn´t be catch.So the patient swallowed it.The patient was sent to the emergency room where a x-ray was taken.No further action was taken on the patient.

• Brand Name: INTRA LUX HEAD 68 LH
• Type of Device: DENTAL HANDPIECE ATTACHEMENT
• Manufacturer (Section D): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, 88400 ; GM 88400
• Manufacturer (Section G): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, 88400 ; GM 88400
• Manufacturer Contact: klaus reisenauer ; bismarckring 39; biberach / riss, 88400 ; GM 88400
• MDR Report Key: 12172346
• MDR Text Key: 261690614
• Report Number: 3003637274-2021-00025
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K073478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 68 LH
• Device Catalogue Number: 0.540.2040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2003
• 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