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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 Problem Optical Problem (3001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/03/2021
Event Type  malfunction  
Manufacturer Narrative
Product analysis: analysis confirmed that the device was cloudy.Service found that the outer tube and the tip lens were scratched and that the inner lens was damaged.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from service and repair via manufacturer representative regarding a device used for spinal therapy.It was reported that device was cloudy. there were no further complications reported regarding the event.Update: procedure involved: med the product came in contact with the patient.There was no impact to the patient.
 
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Brand Name
METRX SYSTEM
Type of Device
ARTHROSCOPE
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 Key12880381
MDR Text Key286345459
Report Number1030489-2021-01464
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,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9560100
Device Catalogue Number9560100
Device Lot Number1586863
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2021
Date Manufacturer Received11/05/2021
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 Unknown
Patient Sequence Number1
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