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U.S. Department of Health and Human Services

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

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INTEGRA YORK, PA INC. RUBBER DAM CLAMP FORCEP M51 - GENERAL DENTISTRY Back to Search Results
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.
 
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Brand NameRUBBER DAM CLAMP FORCEP
Type of DeviceM51 - 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 Key10852069
MDR Text Key216653362
Report Number2523190-2020-00142
Device Sequence Number1
Product Code EJG
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 Received11/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number7623
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 Received11/20/2020
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

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