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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
Model Number 9560100
Device Problems Crack (1135); Optical Problem (3001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/23/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from healthcare professional via manufacturer representative regarding a patient having spinal fixation due to lumbar disc herniation. It was reported that there is a crack on the scope lens and the image was cloudy. There were no patient symptoms/ complications as a result of the event.
 
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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
glen belmer
1800 pyramid place
memphis, TN 38132
6122713209
MDR Report Key12157305
MDR Text Key263460311
Report Number1030489-2021-00915
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 Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9560100
Device Catalogue Number9560100
Device Lot Number1586853
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/07/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/17/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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