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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 Problem Image Display Error/Artifact (1304)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/01/2016
Event Type  malfunction  
Manufacturer Narrative
Neither the product nor applicable imaging films were returned to manufacturer for evaluation therefore cause of event cannot be determined.
 
Event Description
It was reported that patient underwent micro endoscopic laminectomy due to spinal canal stenosis. Intra-op, malfunction in images of the scope was observed. Black-dot is seen. No patient complications were reported.
 
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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
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key5976247
MDR Text Key55563923
Report Number1030489-2016-02651
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 09/02/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9560100
Device Lot Number9560100
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 Received09/02/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/18/2013
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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