N/A 9561524Recalls & reported problems

Summary

The FDA's MAUDE database contains 494 adverse event reports that list this exact device (DI 00721902974816), received between Sep 26, 2018 and Sep 29, 2026 — classified as 1 injury, 493 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (320 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 494 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break

  Information was received from multiple sources (Manufacturer Representative, User Facility) regarding a flex arm. It was reported th at there is Breakage of the handle section (red washer). It was unknown if there is patient involved. There were no further complications reported regarding the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929257 ↗
• MalfunctionAug 28, 2026Break; Degraded; Mechanics Altered

  Additional information was received from the manufacturer representative that Apparently the problem is wear and tear on the part.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50500198 ↗
• MalfunctionAug 5, 2026Mechanics Altered

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50142465 ↗
• MalfunctionAug 5, 2026Mechanics Altered

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50137129 ↗
• MalfunctionJun 30, 2026Mechanics Altered

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A DEVICE USED FOR SPINAL THERA PY. IT WAS REPORTED THAT EVEN WHEN THE DISC WAS TIGHTENED, THE INSTRUMENT WAS NOT FIXATED. 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 25662311 ↗
• MalfunctionJun 27, 2026Mechanics Altered

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A FLEX ARM USED FOR SPINAL THERAPY. IT WAS REPORTED THAT FLEX ARM WAS NOT BEING FIXED. 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 25645183 ↗
• MalfunctionJun 17, 2026Mechanical Problem

  INFORMATION RECEIVED FROM THE DISTRIBUTOR VIA A MANUFACTURER REPRESENTATIVE REGARDING MULTIPLE DEVICES USED FOR SPINAL THERAPY. IT W AS REPORTED THAT THE INSTRUMENT HAS DIFFICULTY ADJUSTING THE ARM. IT DOESN'T LOCK SECURELY AND COMES LOOSE, WHICH CREATES A DEFICIENCY IN ITS USE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25528315 ↗
• MalfunctionJun 17, 2026Mechanical Problem

  INFORMATION RECEIVED FROM THE DISTRIBUTOR VIA A MANUFACTURER REPRESENTATIVE REGARDING MULTIPLE DEVICES USED FOR SPINAL THERAPY. IT W AS REPORTED THAT THE INSTRUMENT HAS DIFFICULTY ADJUSTING THE ARM. IT DOESN'T LOCK SECURELY AND COMES LOOSE, WHICH CREATES A DEFICIENCY IN ITS USE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25528227 ↗
• MalfunctionJun 17, 2026Mechanical Problem

  INFORMATION RECEIVED FROM THE DISTRIBUTOR VIA A MANUFACTURER REPRESENTATIVE REGARDING MULTIPLE DEVICES USED FOR SPINAL THERAPY. IT W AS REPORTED THAT THE INSTRUMENT HAS DIFFICULTY ADJUSTING THE ARM. IT DOESN'T LOCK SECURELY AND COMES LOOSE, WHICH CREATES A DEFICIENCY IN ITS USE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25528203 ↗
• MalfunctionJun 17, 2026Mechanical Problem

  INFORMATION RECEIVED FROM THE DISTRIBUTOR VIA A MANUFACTURER REPRESENTATIVE REGARDING MULTIPLE DEVICES USED FOR SPINAL THERAPY. IT W AS REPORTED THAT THE INSTRUMENT HAS DIFFICULTY ADJUSTING THE ARM. IT DOESN'T LOCK SECURELY AND COMES LOOSE, WHICH CREATES A DEFICIENCY IN ITS USE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25528188 ↗
• MalfunctionJun 17, 2026Mechanical Problem

  INFORMATION RECEIVED FROM THE DISTRIBUTOR VIA A MANUFACTURER REPRESENTATIVE REGARDING MULTIPLE DEVICES USED FOR SPINAL THERAPY. IT W AS REPORTED THAT THE INSTRUMENT HAS DIFFICULTY ADJUSTING THE ARM. IT DOESN'T LOCK SECURELY AND COMES LOOSE, WHICH CREATES A DEFICIENCY IN ITS USE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25528165 ↗
• MalfunctionJun 17, 2026Mechanical Problem

  INFORMATION RECEIVED FROM THE DISTRIBUTOR VIA A MANUFACTURER REPRESENTATIVE REGARDING MULTIPLE DEVICES USED FOR SPINAL THERAPY. IT W AS REPORTED THAT THE INSTRUMENT HAS DIFFICULTY ADJUSTING THE ARM. IT DOESN'T LOCK SECURELY AND COMES LOOSE, WHICH CREATES A DEFICIENCY IN ITS USE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25528154 ↗
• MalfunctionJun 17, 2026Mechanical Problem

  INFORMATION RECEIVED FROM THE DISTRIBUTOR VIA A MANUFACTURER REPRESENTATIVE REGARDING MULTIPLE DEVICES USED FOR SPINAL THERAPY. IT W AS REPORTED THAT THE INSTRUMENT HAS DIFFICULTY ADJUSTING THE ARM. IT DOESN'T LOCK SECURELY AND COMES LOOSE, WHICH CREATES A DEFICIENCY IN ITS USE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25528110 ↗
• MalfunctionJun 17, 2026Mechanical Problem

  INFORMATION RECEIVED FROM THE DISTRIBUTOR VIA A MANUFACTURER REPRESENTATIVE REGARDING MULTIPLE DEVICES USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENT HAS DIFFICULTY ADJUSTING THE ARM. IT DOESN'T LOCK SECURELY AND COMES LOOSE, WHICH CREATES A DEFICIENCY IN ITS USE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25528085 ↗
• MalfunctionJun 16, 2026Product Quality Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE DESIGN UPDATE CHANGED THE LOCK COMPONENT FROM METAL TO PLASTIC, AND THIS CHANGE GENERATED A PRODUCT PERFORMANCE DEFICIENCY BECAUSE THE INSTRUMENT WAS REPORTED TO BE LESS DURABLE THAN BEFORE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25514695 ↗
• MalfunctionJun 16, 2026Product Quality Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE DESIGN UPDATE CHANGED THE LOCK COMPONENT FROM METAL TO PLASTIC, AND THIS CHANGE GENERATED A PRODUCT PERFORMANCE DEFICIENCY BECAUSE THE INSTRUMENT WAS REPORTED TO BE LESS DURABLE THAN BEFORE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25514682 ↗
• MalfunctionJun 16, 2026Product Quality Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE DESIGN UPDATE CHANGED THE LOCK COMPONENT FROM METAL TO PLASTIC, AND THIS CHANGE GENERATED A PRODUCT PERFORMANCE DEFICIENCY BECAUSE THE INSTRUMENT WAS REPORTED TO BE LESS DURABLE THAN BEFORE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25514580 ↗
• MalfunctionJun 16, 2026Product Quality Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE DESIGN UPDATE CHANGED THE LOCK COMPONENT FROM METAL TO PLASTIC, AND THIS CHANGE GENERATED A PRODUCT PERFORMANCE DEFICIENCY BECAUSE THE INSTRUMENT WAS REPORTED TO BE LESS DURABLE THAN BEFORE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25514117 ↗
• MalfunctionJun 16, 2026Product Quality Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE DESIGN UPDATE CHANGED THE LOCK COMPONENT FROM METAL TO PLASTIC, AND THIS CHANGE GENERATED A PRODUCT PERFORMANCE DEFICIENCY BECAUSE THE INSTRUMENT WAS REPORTED TO BE LESS DURABLE THAN BEFORE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25514114 ↗
• MalfunctionJun 12, 2026Product Quality Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, DISTRIBUTOR) REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENTS WAS USED IN SPINE PROCEDURES AND, AFTER AN UPDATE TO THE LOCKING AREA IN WHICH THE LOCK MATERIAL CHANGED FROM METAL TO PLASTIC, THE PRODUCT PERFORMANCE WAS ALLEGED TO BE DEFICIENT AND LESS DURABLE THAN PREVIOUSLY. THE PRODUCT WAS REPORTED TO HAVE BEEN UTILIZED CORRECTLY ACCORDING TO THE INSTRUCTIONS FOR USE/LABELING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25481443 ↗
• MalfunctionJun 12, 2026Product Quality Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, DISTRIBUTOR) REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENTS WAS USED IN SPINE PROCEDURES AND, AFTER AN UPDATE TO THE LOCKING AREA IN WHICH THE LOCK MATERIAL CHANGED FROM METAL TO PLASTIC, THE PRODUCT PERFORMANCE WAS ALLEGED TO BE DEFICIENT AND LESS DURABLE THAN PREVIOUSLY. THE PRODUCT WAS REPORTED TO HAVE BEEN UTILIZED CORRECTLY ACCORDING TO THE INSTRUCTIONS FOR USE/LABELING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25481438 ↗
• MalfunctionJun 12, 2026Product Quality Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, DISTRIBUTOR) REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENTS WAS USED IN SPINE PROCEDURES AND, AFTER AN UPDATE TO THE LOCKING AREA IN WHICH THE LOCK MATERIAL CHANGED FROM METAL TO PLASTIC, THE PRODUCT PERFORMANCE WAS ALLEGED TO BE DEFICIENT AND LESS DURABLE THAN PREVIOUSLY. THE PRODUCT WAS REPORTED TO HAVE BEEN UTILIZED CORRECTLY ACCORDING TO THE INSTRUCTIONS FOR USE/LABELING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25481437 ↗
• MalfunctionJun 12, 2026Product Quality Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, DISTRIBUTOR) REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENTS WAS USED IN SPINE PROCEDURES AND, AFTER AN UPDATE TO THE LOCKING AREA IN WHICH THE LOCK MATERIAL CHANGED FROM METAL TO PLASTIC, THE PRODUCT PERFORMANCE WAS ALLEGED TO BE DEFICIENT AND LESS DURABLE THAN PREVIOUSLY. THE PRODUCT WAS REPORTED TO HAVE BEEN UTILIZED CORRECTLY ACCORDING TO THE INSTRUCTIONS FOR USE/LABELING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25481430 ↗
• MalfunctionMay 15, 2026Mechanics Altered

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING MINIMALLY INVASIVE SPINE DE COMPRESSION. IT WAS REPORTED THAT THE FLEXIBLE ARM DID NOT TIGHTEN PROPERLY TO HOLD THE METRX TUBES RIGID. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25182530 ↗
• MalfunctionMay 14, 2026Break

  INFORMATION WAS RECEIVED FROM THE USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TIGHTENING HANDLE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED AS INSTRUMENTS WERE USED NUMEROUS TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25167549 ↗