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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC METRX SYSTEM ARTHROSCOPE

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MEDTRONIC SOFAMOR DANEK USA, INC METRX SYSTEM ARTHROSCOPE Back to Search Results
Catalog Number 9560100
Device Problems Crack (1135); No Display/Image (1183); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/25/2020
Event Type  malfunction  
Manufacturer Narrative
Product was not returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient underwent micro-endoscopic discectomy. During the surgery, it was found that when the reported product was connected to the camera head, the monitor image seemed to be misty and the image did not display properly. There was no patient involved in this event. When the product was checked, no scratches or damage were found on the tip lens surface, but it was scratched and deformed at the corners of the l-shaped part of the body. Also, when seen inside from the camera head side, it seems there were foreign material and cracks.
 
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Brand NameMETRX SYSTEM
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer Contact
stacie ziemba
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key9863789
MDR Text Key184473478
Report Number1030489-2020-00351
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K002931
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 03/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9560100
Device Lot Number1462729
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 Received02/25/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/17/2019
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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