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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: S.S. WHITE BURS, INC. GREAT WHITE GOLD SERIES METAL CUTTING CAVITY PREPARATION CARBIDE BUR; DENTAL BUR
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S.S. WHITE BURS, INC. GREAT WHITE GOLD SERIES METAL CUTTING CAVITY PREPARATION CARBIDE BUR; DENTAL BUR Back to Search Results
Model Number GW-557
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 06/06/2018
Event Type  Injury  
Event Description
During dental oral rehabilitation procedure, under anesthesia, dentist was using carbide bur for cavity purposes.Distal tip of bur broke off during procedure, and could not be located in patient¿s mouth or oropharynx.Pack in place surrounding et tube; anesthesiologist could not locate tip.Patient taken to hospital emergency room for evaluation of retained foreign body.X-rays taken; tip not identified in stomach or lungs.Diagnosis or reason for use: dental cavities."is the product compounded: no; is the product over-the-counter: yes".
 
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Brand Name
GREAT WHITE GOLD SERIES METAL CUTTING CAVITY PREPARATION CARBIDE BUR
Type of Device
DENTAL BUR
Manufacturer (Section D)
S.S. WHITE BURS, INC.
1145 towbin ave
lakewood NJ 08701
MDR Report Key7742365
MDR Text Key116073722
Report NumberMW5078771
Device Sequence Number0
Product Code EJL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 07/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2018
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberGW-557
Device Catalogue Number18218
Device Lot Number2017-05-31
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age4 YR
Patient Weight21
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