METRx SystemRecalls & reported problems across all models
Medtronic Sofamor Danek, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 672
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 5 models of METRx System by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 672 adverse event reports in the FDA's MAUDE database, received between Oct 11, 2017 and Sep 28, 2026 — classified as 4 injuries, 668 malfunctions.
The most frequently reported specific device problem is “Optical Problem” (602 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported METRx System problems
Device problems
- Optical Problem602
- Scratched Material52
- Contamination /Decontamination Problem45
- Break26
- Crack22
- Material Deformation16
- Poor Quality Image14
- Display or Visual Feedback Problem10
Patient problems
- No Clinical Signs, Symptoms or Conditions647
- No Known Impact Or Consequence To Patient33
- Burn(s)1
METRx System models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- METRx® System 9560100Arthroscope667 reports
- METRx® System 9560757ARTHROSCOPE2 reports
- METRx® System 9560702ARTHROSCOPE1 report
- METRx® System 9560431Accessories, arthroscopic1 report
- METRx® System 9560432Accessories, arthroscopic1 report
Recent METRx System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Scratched Material
Information was received from healthcare provider (HCP) via the multiple sources (manufacturer representative, Service & Repair) regarding an Endoscope used on patient having Spinal therapy. It was reported that there were scratches on the lens. There was no patient involved in this event. There were no further complications reported regarding the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911084 ↗MalfunctionSep 25, 2026Optical Problem
Information was received from user facility via manufacturing representative regarding a product identified during an event. It was reported that cloudy images, loose couplers and scratches on outer tubes. No patient was involved in this event. No further complications were reported/anticipated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896189 ↗MalfunctionSep 17, 2026Optical Problem
Information was received from healthcare provider (HCP) via a manufacturer representative regarding a product used for spinal therapy. It was reported that after the scope is attached, the surgical field does not display clearly. There were no further complications or symptoms reported regarding the event. Additional information was received via manufacturer representative that the issue was associated with scope.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802884 ↗MalfunctionSep 15, 2026Optical Problem
Information was received from user facility via a manufacturer representative regarding a device used for Spinal therapy. It was rep orted that the focus adjustment function was defective and image was blurred. There was no patient involvement reported. There were no further complications reported regarding the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775073 ↗MalfunctionSep 15, 2026Optical Problem
Information was received from a healthcare provider via Manufacturer Representative regarding a device used for Spinal therapy. It was reported that the image was cloudy. The event occurred preoperatively and there was no patient involvement reported. There were no further complications reported regarding the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50774831 ↗MalfunctionAug 27, 2026Break; Optical Problem
Information was received from a healthcare professional regarding endoscopes. It was reported that there is Cloudiness due to lens breakage. There was no patient symptoms reported. There were no further complications reported regarding the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50471474 ↗MalfunctionAug 27, 2026Break; Optical Problem
Information was received from a heathcare professional regarding endoscopes. It was reported that there is Cloudiness due to lens br eakage. There was no patient symptoms reported. There were no further complications reported regarding the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50471378 ↗MalfunctionAug 13, 2026Optical Problem
Information was received from multiple sources (Manufacturer Representative, User Facility) regarding a device used for Spinal thera py. It was reported that the image was cloudy/hazy. There was no patient symptom reported. There were no further complications reported regarding the event. Additional information was received from the manufacturer representative stating that the event occured pre operatively.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50231207 ↗MalfunctionAug 11, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50205195 ↗MalfunctionAug 5, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50140615 ↗MalfunctionJul 31, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50100861 ↗MalfunctionJul 28, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50057756 ↗MalfunctionJul 28, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50051995 ↗MalfunctionMay 26, 2026Optical Problem
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE FIELD OF VIEW OF ENDOSCOPE WAS NOT CLEAR/CLOUDY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25273594 ↗MalfunctionMay 20, 2026Optical Problem; Scratched Material
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY, SERVICE REPAIR) REGARDING AN ENDOSCOPE HAVING SPINAL THERAPY. IT WAS REPORTED THAT LENS HAD BLACK SPOTS AND SCRATCHES. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25228009 ↗
Other Medtronic Sofamor Danek, Inc. products
- CD HORIZON Spinal System342 models · 2,323 reports
- GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM)25 models · 12 reports · 14 recalls
- INFUSE Bone Graft6 models · 576 reports · 1 recall
- CD HORIZON SOLERA VOYAGER Spinal System60 models · 411 reports
- POWEREASE Instruments8 models · 331 reports · 1 recall
- Catalyft PL Expandable Interbody System16 models · 279 reports · 1 recall
- INFINITY Occipitocervical Upper Thoracic System35 models · 63 reports · 5 recalls
- Catalyft LS Expandable Interbody System6 models · 3 reports · 6 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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