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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY LLC PALODENT V3 UNIV 2 RING REFIL; INSTRUMENTS, DENTAL HAND

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DENTSPLY LLC PALODENT V3 UNIV 2 RING REFIL; INSTRUMENTS, DENTAL HAND Back to Search Results
Catalog Number 659760V
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2024
Event Type  malfunction  
Manufacturer Narrative
While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.This event, therefore, is reportable per 21cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
 
Event Description
In this event it is reported that palodent v3 univ 2 ring refil broke during use.
 
Manufacturer Narrative
Failure mode: broken product.Root cause: no defect proven.Conclusion code: no failure found.6-4-2024: dhr for item# (b)(4) batch# 06616069 has been pulled, reviewed, and attached to this case.Dhr review did not indicate any production issues while packaging/labeling the palodent v3 univ 2 ring refill.Work order (b)(4) is the packaging work order which utilized over-molding of the springs to rings production work order/run for item# (b)(4) (v5 ring universal - palodent) batch# 06603963 (produced 04-2023).Dhr for item# (b)(4) batch# 06603963 has also been pulled, reviewed, and attached to this case.Dhr review did not identify any issues during production, with all inspections performed and deemed acceptable by the operator(s) and quality as per 0290-wi-7.5-60-14 & 0290-ip-7.5-60-58.(nwv).6-4-2024: final product retains are not kept as per normal procedure.Retains from overmolding item# (b)(4) batch# 06603963 were reviewed and inspected per 0290-ip-7.5-60-58 and were found acceptable.(nwv).
 
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Brand Name
PALODENT V3 UNIV 2 RING REFIL
Type of Device
INSTRUMENTS, DENTAL HAND
Manufacturer (Section D)
DENTSPLY LLC
38 west clarke avenue
milford DE 19963
Manufacturer (Section G)
DENTSPLY LLC
38 west clarke avenue
milford DE 19963
Manufacturer Contact
hannah seevaratnam
221 west philadelphia st.
york, PA 17401
7178457511
MDR Report Key19058916
MDR Text Key339581630
Report Number2515379-2024-00017
Device Sequence Number1
Product Code DZN
UDI-Device IdentifierD002659760V1
UDI-PublicD002659760V1
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
EXEMPT
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 04/08/2024
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 Catalogue Number659760V
Device Lot Number06616069
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date04/06/2024
Initial Date Manufacturer Received 04/06/2024
Initial Date FDA Received04/08/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage A
Patient Sequence Number1
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