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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY CAULK PALODENT PLUS SECTIONAL MATRIX RING; INSTRUMENTS, DENTAL HAND
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DENTSPLY CAULK PALODENT PLUS SECTIONAL MATRIX RING; INSTRUMENTS, DENTAL HAND Back to Search Results
Catalog Number 659770
Device Problem Break (1069)
Patient Problems Tooth Fracture (2428); Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative
Since this event resulted in permanent damage to a body structure or permanent impairment of a body function that would require intervention, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur.As such, this event meets the definition of a reportable event per 21 cfr 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
It was reported that a palodent sectional matrix ring broke during use and chipped a patient's tooth.The event outcome is unknown as of this mdr evaluation.
 
Manufacturer Narrative
Multiple unsuccessful attempts were made to obtain the device for evaluation.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
 
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Brand Name
PALODENT PLUS SECTIONAL MATRIX RING
Type of Device
INSTRUMENTS, DENTAL HAND
Manufacturer (Section D)
DENTSPLY CAULK
38 w. clark ave.
milford DE 19963
MDR Report Key10938751
MDR Text Key219318849
Report Number2515379-2020-00009
Device Sequence Number1
Product Code DZN
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number659770
Was Device Available for Evaluation? No
Date Manufacturer Received01/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age26 YR
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