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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KAVO DENTAL GMBH MASTERTORQUE MINI LUX M8700 L; DENTAL HANDPIECE
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KAVO DENTAL GMBH MASTERTORQUE MINI LUX M8700 L; DENTAL HANDPIECE Back to Search Results
Model Number M8700L
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/28/2020
Event Type  Injury  
Event Description
The dentist was performing a dental procedure using a kavo mastertorque mini lux m8700 l dental handpiece when allegedly the dental bur separated from the handpiece and was swallowed by the patient.The patient was taken to the hospital and x-rays were taken which showed the object was ready to pass and no further treatment was required.Follow up was made by the dental facility office manager on (b)(6) 2020 with the mother of the patient, she stated that the patient had passed the bur.There were no injuries reported.
 
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Brand Name
MASTERTORQUE MINI LUX M8700 L
Type of Device
DENTAL HANDPIECE
Manufacturer (Section D)
KAVO DENTAL GMBH
bismarckring 39
biberach / riss 88400 , DE
GM  88400, DEU
MDR Report Key10958827
MDR Text Key219887870
Report Number1017522-2020-00013
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM8700L
Device Catalogue Number3.001.0000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/07/2020
Distributor Facility Aware Date11/05/2020
Device Age5 YR
Event Location Other
Date Report to Manufacturer11/05/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age4 YR
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