MAUDE Adverse Event Report: DEN-MAT HOLDINGS, LLC. CERI-SAW; INSTRUMENTS, DENTAL HAND

Catalog Number 031336510

Device Problems Labelling, Instructions for Use or Training Problem (1318); Problem with Sterilization (1596)

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

Event Type  malfunction  

Event Description

Contacted denmat holdings regarding instruction for use for their cerisaw anterior finishing system.There were no instructions for use for cleaning or sterilization provided contacted customer service / regulatory.Was told to autoclave but cannot provide a temperature, exposure time or cycle type.Requested specific info and was told to sterilize at 400 to 425 degree f.Advised the company this was unacceptable and we will be reporting them to the fda for f/u.

• Brand Name: CERI-SAW
• Type of Device: INSTRUMENTS, DENTAL HAND
• Manufacturer (Section D): DEN-MAT HOLDINGS, LLC.
• MDR Report Key: 17079507
• MDR Text Key: 316774087
• Report Number: MW5118221
• Device Sequence Number: 1
• Product Code: DZN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 031336510
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1