MAUDE Adverse Event Report: INTEGRA YORK, PA INC. RUBBER DAM CLAMP FORCEP M51 - GENERAL DENTISTRY

Catalog Number 7623

Device Problem Break (1069)

Patient Problem Tooth Fracture (2428)

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information. Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A dental facility reported that during use on a patient, the right tip of the miltex rubber dam clamp forceps broke off. Additional information from facility clarified the forceps chipped tooth number 24 incisal lingual edge while holding the rubber dam in place. This brought the patient to tears and the dentist had to fix the chipped tooth. The procedure was delayed by 20 minutes due to the chipped tooth. No additional information was provided.

• Brand Name: RUBBER DAM CLAMP FORCEP
• Type of Device: M51 - GENERAL DENTISTRY
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• Manufacturer (Section G): INTEGRA YORK, PA INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: vivian nelson ; 1000 campus drive; princeton, NJ 08536 ; 6099362319
• MDR Report Key: 10852069
• MDR Text Key: 216653362
• Report Number: 2523190-2020-00142
• Device Sequence Number: 1
• Product Code: EJG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 7623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/20/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown