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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PALISADES DENTAL, LLC IMPACT AIR 45 HANDPIECE

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PALISADES DENTAL, LLC IMPACT AIR 45 HANDPIECE Back to Search Results
Model Number 407
Device Problems Use of Device Problem (1670); Device Handling Problem (3265)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Palisades dental was notified on (b)(6) 2019 that a clinical incident occured sometime in (b)(6) 2018 as "the handpiece was used to section a tooth in the upper quadrant. The bur rotated within the chuck of the handpiece and dislodged. The patient had a rubber dam barrier in place, isolating the tooth and quadrant. The bur was retrieved without incident". Though no medical/surgical intervention was required to preclude a serious injury in this event, there have been previously reported events involving a similar 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. Palisades dental performed an investigation and concluded that the failure is not manufacture related, rather related to the failure of following instructions for use.
 
Event Description
Palisades dental was notified on (b)(6) 2019 that a clinical incident occured sometime during (b)(6) 2018 as "the handpiece was used to section a tooth in the upper quadrant. The bur rotated within the chuck of the handpiece and dislodged. The patient had a rubber dam barrier in place, isolating the tooth and quadrant. The bur was retrieved without incident". The reported complaint did not result in an injury or need for intervention. The dentist could not provide the specific date of the incident or any details regarding the patient.
 
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Brand NameIMPACT AIR 45
Type of DeviceHANDPIECE
Manufacturer (Section D)
PALISADES DENTAL, LLC
111 cedar lane
englewood NJ 07631
Manufacturer (Section G)
PALISADES DENTAL, LLC
111 cedar lane
englewood NJ 07631
Manufacturer Contact
maureen mcgovern
111 cedar lane
englewood, NJ 07631
2015690050
MDR Report Key8370179
MDR Text Key139825392
Report Number3003963943-2019-00001
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K972376
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Dentist
Type of Report Initial
Report Date 02/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number407
Device Lot Number7541
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/23/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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