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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS BUR BUR, EAR, NOSE AND THROAT

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MEDTRONIC XOMED INC. XPS BUR BUR, EAR, NOSE AND THROAT Back to Search Results
Model Number 1883672HS
Device Problems Material Fragmentation (1261); Mechanical Jam (2983)
Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Event Date 06/15/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported via health care professional that some of the diamond burs were used in a case and 2 of them were broken. Upon follow up it was confirmed that one of the burs's tip broke off completely and the other one just failed to work. It wouldn¿t spin. There were fragments. The fragments had to be removed from the patient.
 
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Brand NameXPS BUR
Type of DeviceBUR, EAR, NOSE AND THROAT
Manufacturer (Section D)
MEDTRONIC XOMED INC.
6743 southpoint dr n
jacksonville FL 32216
Manufacturer (Section G)
MEDTRONIC XOMED INC.
6743 southpoint dr n
jacksonville FL 32216
Manufacturer Contact
tricha miles
6743 southpoint drive north
jacksonville, FL 32216
7635140379
MDR Report Key10269188
MDR Text Key198684349
Report Number1045254-2020-00311
Device Sequence Number1
Product Code EQJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1883672HS
Device Catalogue Number1883672HS
Device Lot Number0213146585
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 Received07/14/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/13/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/14/2020 Patient Sequence Number: 1
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