N/A 9560524Recalls & reported problems

Summary

The FDA's MAUDE database contains 866 adverse event reports that list this exact device (DI 00721902322556), received between Feb 18, 2018 and Sep 30, 2026 — classified as 6 injuries, 860 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (622 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 866 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Mechanics Altered

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding a device used for Spinal therapy. It was reported that during the preoperative inspection before the first procedure after repair, rotation was found at a part on the tubular retractor connection side that should not have rotated. 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 50947051 ↗
• MalfunctionSep 28, 2026Mechanics Altered

  Information was received from user facility via manufacturing representative regarding a product identified during an event. It was reported that instrument functional decline rotating disc issue. No patient was involved in this event. No further complications were reported/anticipated.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910776 ↗
• MalfunctionSep 23, 2026Mechanics Altered

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding a Patient having Micro Endoscopic Discectomy therapy Lumbar disc herniation. It was reported that during the operation on 2nd Sep 2026, the distal end was reported to have rotated, preventing the tubular retractor from being connected at the optimal position. On 3rd Sep 2026, review of photographs confirmed that the distal end had shifted into a slightly rotated position. There was no patient symptom reported. There were no further complications reported regarding the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865337 ↗
• MalfunctionSep 23, 2026Mechanics Altered

  Information was received from the Healthcare professional via a manufacturer representative regarding a device used for spinal therapy. It was reported that the instrument cannot be fixated. There were no patient symptoms reported. There were no further complications reported regarding the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863385 ↗
• MalfunctionSep 21, 2026Mechanics Altered

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding a Patient having Microendoscopic Discectomy. It was reported that the fixing screw was rotated, it could not be fixed to the post, and handle does not rotate. Also the camera part at the tip is reported to be loose. There was no patient symptom reported. The patient was present at the time of the event, but since it was discovered during procedure preparation, there was no impact on the patient. There were no further complications reported regarding the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50845725 ↗
• MalfunctionSep 17, 2026Mechanics Altered

  Information was received from healthcare professional via multiple sources (Manufacturer Representative, Service Repair) regarding a Flex arm used for Spinal therapy. It was reported that the drum did not rotate/turn. Event occurred at the start of the procedure and 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 50799933 ↗
• MalfunctionSep 16, 2026Mechanics Altered; Naturally Worn

  Information was received from the multiple sources (User Facility, manufacturer representative) regarding a Flex Arm used for tubular decompression therapy. It was reported that the most distal joint closest to the tube has become worn down and lacks the ability to completely tighten when engaged. 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 50785052 ↗
• MalfunctionSep 15, 2026Mechanics Altered

  Information was received from multiple sources (Manufacturer Representative, User Facility) regarding a product used for spinal therapy. It was reported that the instrument cannot be fixed. There was no patient involvement reported, and no further complications or symptoms reported regarding the event. Additional information was received via manufacturer representative that the reported product was already used before.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50775204 ↗
• MalfunctionSep 15, 2026Mechanics Altered

  Information was received from a healthcare provider regarding a Patient having Spinal therapy. It was reported that the tip of the device is loose. 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 issue was confirmed during inspection prior to use for surgery therefore it was not used during the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50769160 ↗
• MalfunctionSep 9, 2026Mechanics Altered

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50684487 ↗
• MalfunctionSep 2, 2026Mechanics Altered

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50557931 ↗
• MalfunctionSep 2, 2026Mechanics Altered

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50557864 ↗
• MalfunctionSep 1, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50546363 ↗
• MalfunctionSep 1, 2026Mechanics Altered

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50544262 ↗
• MalfunctionAug 31, 2026Material Deformation; Mechanics Altered

  Information was received from multiple sources (Manufacturer Representative, User Facility) regarding a product used for spinal ther apy. It was reported that there was malfunction with the rotating disk of the device. There was no patient involvement reported and no further complications reported regarding the event. Additional information was received via manufacturer representative that the handle threads were deformed and the reported issue was not a manufacturing issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50519111 ↗
• MalfunctionAug 18, 2026Mechanics Altered

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50298685 ↗
• MalfunctionAug 4, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50125019 ↗
• MalfunctionJul 14, 2026Mechanics Altered

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25809504 ↗
• MalfunctionJul 13, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25791842 ↗
• MalfunctionJun 24, 2026Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PRODUCT USED IN MICRO ENDOSCOPIC DISCECTOMY (MED) SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE HAD LOCK FAILURE ISSUE. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25605389 ↗
• MalfunctionJun 18, 2026Mechanics Altered

  INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE REGARDING A FLEX ARM. IT WAS REPORTED THAT THERE IS ROTATE TABLE FUNCTION DECLINE. THERE WERE NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25546416 ↗
• MalfunctionJun 17, 2026Mechanics Altered

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A FLEX ARM USED FOR SPINAL THERAPY. IT WAS R REPORTED THAT THERE WAS A LOSS OF THE ANTI-DROP/DROP-PREVENTION PART OF THE ARM FIXATION SCREW. EVENT OCCURRED DURING POST-OP AND 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 25532809 ↗
• MalfunctionJun 17, 2026Mechanics Altered

  INFORMATION WAS RECEIVED FROM THE MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, SERVICE REPAIR) REGARDING A FLEX ARM USED FOR SPINAL THERAPY. IT WAS REPORTED THAT DECREASED FUNCTION IN FLEX ARM, LOOSENING OF THE ROTATING DISK AND HOLDER SECTION WAS OBSERVED. 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 25531135 ↗
• MalfunctionJun 16, 2026Crack

  INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE, SERVICE REPAIR REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THERE WAS A CRACK IN THE FLEX ARM. 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 25527790 ↗
• MalfunctionJun 16, 2026Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE DRUM DOES NOT ROTATE/TURN. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PROCEDURE INVOLVED IN THE EVENT WAS MICRO ENDOSCOPIC DISCECTOMY (MED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25515567 ↗