METRx® System 9560702Recalls & reported problems
Medtronic Sofamor Danek, Inc. · INSTRUMENT 9560702 RADIANCE ILLUMIN SYS · Class 2
All models of METRx System (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00721902444104), received between Mar 7, 2019 and Mar 7, 2019 — classified as 1 injury.
3 other recalls cover devices cleared under the same FDA submission (K993021); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT INTRA-OP, HEAT BURN TO PATIENT'S BACK WHERE CONNECTION OF LIGHT SOURCE TO LIGHT CORD ATTACHES. RADIANCE LIGHT SOURCE USED WITH SIZE 20 TUBES. THE PROTECTIVE COVERING WAS NOT SLID OVER THE LIGHT SOURCE TO LIGHT CORD CONNECTION. AFTER FIRST TLIF WAS COMPLETE, BURNS WERE NOTICED ON THE PATIENTS BACK AND IDENTIFIED TO BE CAUSED BY THE LIGHT SOURCE/LIGHT CORD CONNECTION. A VASELINE GAUZE WAS IMMEDIATELY PLACED ON THE BURN, AND THE COVERING SLID OVER THE LIGHT SOURCE TO LIGHT CABLE CONNECTION.
Patient problems: Burn(s)
MAUDE report 8398212 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K993021. One submission often covers many models, so check the product and lot details in each record.
- Z-0993-05 · Jun 20, 2005 · TerminatedMedtronic Sofamor Danek brand METRx System MD Procedure Kit; Ref 9560030.
- Z-0991-05 · Jun 20, 2005 · TerminatedMedtronic Sofamor Danek brand METRx System 16 mm Med Procedure Kit; Ref 9560016.
- Z-0992-05 · Jun 20, 2005 · TerminatedMedtronic Sofamor Danek brand METRx System 18 mm Med Procedure Kit; Ref 9560018.
Other ARTHROSCOPE devices
- FMS 283512Medos International Sàrl · ARTHROSCOPE1,800 reports
- Arthrex® AR-6480Arthrex, Inc. · ARTHROSCOPE949 reports
- FMS VUE 284002Depuy Mitek, LLC · ARTHROSCOPE829 reports
- MITEK 242018Medos International Sàrl · Arthroscope731 reports
- METRx® System 9560100Medtronic Sofamor Danek, Inc. · Arthroscope667 reports
- FMS VUE II 284004Medos International Sàrl · Arthroscope562 reports
- VAPR COOLPULSE 228146Depuy Mitek, LLC · ARTHROSCOPE474 reports
- FMS DUO 284580Depuy Mitek, LLC · ARTHROSCOPE458 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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