MAUDE Adverse Event Report: DENTSPLY CAULK PALODENT V3 RING; INSTRUMENTS, DENTAL HAND

Catalog Number 403342

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury.Therefore, this event meets the criteria for reportability per 21 cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it was reported that a palodent v3 universal matrix ring broke during use; no injury resulted.

Manufacturer Narrative

Returned product was a single sterilized bag (without original packaging) and contained 1 v3 ring universal (green) and confirmed to be broken in half at the pivot point.

• Brand Name: PALODENT V3 RING
• Type of Device: INSTRUMENTS, DENTAL HAND
• Manufacturer (Section D): DENTSPLY CAULK; 38 w. clark ave.; milford DE 19963
• MDR Report Key: 11868442
• MDR Text Key: 255134856
• Report Number: 2515379-2021-00009
• Device Sequence Number: 1
• Product Code: DZN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/22/2021

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 Number: 403342
• Device Lot Number: 00199933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/22/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1