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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY IMPLANTS TWIST DRILL 2.0, 8-19 MM; DENTAL BUR
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DENTSPLY IMPLANTS TWIST DRILL 2.0, 8-19 MM; DENTAL BUR Back to Search Results
Catalog Number 22886
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
The customer reported that a twist drill broke during use.The session was completed successfully by using a different drill.
 
Manufacturer Narrative
Though no medical/surgical intervention was required to preclude a serious injury in this event, there have been previously reported events involving this device that resulted in the need for medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function.Therefore, this event meets the criteria for reportability per 21 cfr part 803.
 
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Brand Name
TWIST DRILL 2.0, 8-19 MM
Type of Device
DENTAL BUR
Manufacturer (Section D)
DENTSPLY IMPLANTS
molndal
SW 
Manufacturer Contact
helen lewis
221 w. philadelphia st
ste. 60, susquehanna commerce ctr w
york, PA 17401
7178457511
MDR Report Key4456815
MDR Text Key5424609
Report Number9612468-2014-00016
Device Sequence Number1
Product Code EJL
Combination Product (y/n)N
Reporter Country CodeIR
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Unknown
Reporter Occupation Dentist
Type of Report Initial
Report Date 09/29/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number22886
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer10/16/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/29/2014
Initial Date FDA Received01/21/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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