METRx® System 9560757Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00721902663444), received between Jul 13, 2020 and Jul 13, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2020Material Separation; Material Separation

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH STENOSIS SPONDYLOLISTHESIS FOR SPINAL THERAPY. PATIENT DEMOGRAPHICS: GENDER: MALE; AGE: (B)(6). OUTCOME: ALIVE NO INJURY. EVENT WAS INTRA-OP. PROCEDURE USED WAS MAST TLIF. LEVELS IMPLANTED: L4-S1 IT WAS REPORTED THAT THE LIGHT SOURCE IS INSERTED INTO THE METRX TUBE PER ITS IFU. HOWEVER, AFTER ABOUT AN HOUR, THE LIGHT SOURCE COMES APART AT THE END. THE TWO PIECES OF METAL BASICALLY SPLIT IN TWO, WITH ONE PIECE FALLING OFF, EXPOSING THE LIGHT. OF COURSE THE LIGHT IS HOT SO THIS POSES A BURN RISK TO THE PATIENT AS WELL AS THE SURGICAL STAFF. IT ALSO POSES A FIRE HAZARD TO THE PATIENT AND THE OR. LASTLY, THERE IS THE POTENTIAL FOR THE ONE PIECE OF METAL THAT FALLS OFF TO BECOME LODGED INTO THE PATIENT OR FALL INTO THE WOULD BE UNKNOWN TO THE SURGEON AND STAFF. FORTUNATELY IN THIS CASE, NONE OF THESE MORE SERIOUS ISSUES OCCURRED. THE LIGHTS AND THE PIECE OF DISASSOCIATED METAL WERE REMOVED FROM THE PATIENT AND DISCARDED. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10262744 ↗
• MalfunctionJul 13, 2020Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH STENOSIS SPONDYLOLISTHESIS FOR SPINAL THERAPY. PATIENT DEMOGRAPHICS: GENDER: MALE; AGE: (B)(6). OUTCOME: ALIVE NO INJURY. EVENT WAS INTRA-OP. PROCEDURE USED WAS MAST TLIF. LEVELS IMPLANTED: L4-S1 IT WAS REPORTED THAT THE LIGHT SOURCE IS INSERTED INTO THE METRX TUBE PER ITS IFU. HOWEVER, AFTER ABOUT AN HOUR, THE LIGHT SOURCE COMES APART AT THE END. THE TWO PIECES OF METAL BASICALLY SPLIT IN TWO, WITH ONE PIECE FALLING OFF, EXPOSING THE LIGHT. OF COURSE THE LIGHT IS HOT SO THIS POSES A BURN RISK TO THE PATIENT AS WELL AS THE SURGICAL STAFF. IT ALSO POSES A FIRE HAZARD TO THE PATIENT AND THE OR. LASTLY, THERE IS THE POTENTIAL FOR THE ONE PIECE OF METAL THAT FALLS OFF TO BECOME LODGED INTO THE PATIENT OR FALL INTO THE WOULD BE UNKNOWN TO THE SURGEON AND STAFF. FORTUNATELY IN THIS CASE, NONE OF THESE MORE SERIOUS ISSUES OCCURRED. THE LIGHTS AND THE PIECE OF DISASSOCIATED METAL WERE REMOVED FROM THE PATIENT AND DISCARDED. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10262733 ↗

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-0992-05 · Jun 20, 2005 · Terminated
  Medtronic Sofamor Danek brand METRx System 18 mm Med Procedure Kit; Ref 9560018.
• Z-0993-05 · Jun 20, 2005 · Terminated
  Medtronic Sofamor Danek brand METRx System MD Procedure Kit; Ref 9560030.
• Z-0991-05 · Jun 20, 2005 · Terminated
  Medtronic Sofamor Danek brand METRx System 16 mm Med Procedure Kit; Ref 9560016.