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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC CHROMA-LINE II SS KERR RONG 8IN 3MM BITE KERRISON RONGEURS

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CAREFUSION, INC CHROMA-LINE II SS KERR RONG 8IN 3MM BITE KERRISON RONGEURS Back to Search Results
Catalog Number NL4261-83
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/11/2020
Event Type  malfunction  
Manufacturer Narrative
Pr # (b)(4). On (b)(6) 2020 writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event. Writer provided contact information. Device not yet evaluated, if the device is evaluated a follow up will be sent.
 
Event Description
Per attached medwatch report (b)(4): the screw became dislodged from the device, and fell out into the patient. Customer response: what is the date of the event? date of event was on (b)(6) 2020. What was the procedure that was being performed? spinal surgery. How was the screw retrieved? surgeon removed the screw following x-ray visualization of the location. Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? x-ray. What was the patient¿s outcome? surgery concluded without further incident, and the patient discharged without post- operative complications. Was the procedure completed as planned? yes. Can you please send all parts of the instrument for evaluation? yes, all items will be sent back for your evaluation. Do you have the lot number? unsure of lot number. Do you have photos of the reported issue on the instrument? no photos but the device will be returned as requested. No further information available.
 
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Brand NameCHROMA-LINE II SS KERR RONG 8IN 3MM BITE
Type of DeviceKERRISON RONGEURS
Manufacturer (Section D)
CAREFUSION, INC
75 north fairway drive
vernon hills IL 60061
Manufacturer (Section G)
CAREFUSION, INC
75 north fairway drive
vernon hills IL 60061
Manufacturer Contact
anna wehrheim
75 north fairway drive
vernon hills, IL 60061
8015652341
MDR Report Key10549996
MDR Text Key207539732
Report Number1423507-2020-00039
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberNL4261-83
Device Lot NumberXWDT08
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 09/17/2020 Patient Sequence Number: 1
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