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U.S. Department of Health and Human Services

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

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MEDTRONIC XOMED INC. XPS BUR - UNKNOWN BUR, EAR, NOSE AND THROAT Back to Search Results
Model Number XOM UNKNOWN BUR
Device Problems Material Fragmentation (1261); Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/22/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A health care provider reported that the drill bit broke off during the procedure and stuck during the procedure. There was no patient impact. On follow up, it was reported that there were fragments detached from the broken product. There were no fragments that fell on the patient.
 
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Brand NameXPS BUR - UNKNOWN
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 Key10862353
MDR Text Key216944115
Report Number1045254-2020-00560
Device Sequence Number1
Product Code EQJ
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberXOM UNKNOWN BUR
Device Catalogue NumberXOM UNKNOWN BUR
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 Received10/26/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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