MAUDE Adverse Event Report: DENTSPLY CAULK PALODENT PLUS SECTIONAL MATRIX UNIVERSAL RING; INSTRUMENTS, DENTAL HAND

Catalog Number 659760

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Tooth Fracture (2428)

Event Type  Injury  

Manufacturer Narrative

Therefore, because there is a possibility that the device may have caused or contributed to a serious injury, this event meets the criteria for reportability per 21 cfr 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

It was reported that after use of several palodent plus universal matrix rings (exact number unknown) during a filling procedure, it was noticed that several teeth had "hairline fractures" at the margin.The fractures were unnoticed until the procedure was finished.As the defects were noticed after the procedure it is uncertain whether or not the ring caused the issue.

Manufacturer Narrative

Rings look a bit worn with some composite buildup.One of the rings is a bit stretched, tines are further open than new ring.Otherwise nothing abnormal with both rings.

• Brand Name: PALODENT PLUS SECTIONAL MATRIX UNIVERSAL RING
• Type of Device: INSTRUMENTS, DENTAL HAND
• Manufacturer (Section D): DENTSPLY CAULK; 38 w. clark ave.; milford DE 19963
• Manufacturer (Section G): DENTSPLY (N.Z.) LIMITED; 11 marshall road; katikati, bay of plenty 3129 ; NZ 3129
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 5904829
• MDR Text Key: 53037036
• Report Number: 2515379-2016-00021
• Device Sequence Number: 1
• Product Code: DZN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 07/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 659760
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2016
• Initial Date FDA Received: 08/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention