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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY MAILLEFER PENETRATION DRILL; DRILL, DENTAL, INTRAORAL
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DENTSPLY MAILLEFER PENETRATION DRILL; DRILL, DENTAL, INTRAORAL Back to Search Results
Catalog Number C021220030800
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
 
Event Description
In this event it was reported that a penetration drill separated during first use; the separated piece was retrieved without injury.
 
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Brand Name
PENETRATION DRILL
Type of Device
DRILL, DENTAL, INTRAORAL
Manufacturer (Section D)
DENTSPLY MAILLEFER
chemin du verger 3
ballaigues, 1338
SZ  1338
Manufacturer (Section G)
DENTSPLY MAILLEFER
chemin du verger 3
ballaigues, 1338
SZ   1338
Manufacturer Contact
karl nittinger
221 w. philadelphia st.
suite 60w
york, PA 17401
7178494424
MDR Report Key11632279
MDR Text Key246028444
Report Number8031010-2021-00055
Device Sequence Number1
Product Code DZA
Combination Product (y/n)N
Reporter Country CodeHU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 04/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberC021220030800
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Unknown
Patient Sequence Number1
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