N/A 9560523Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00721902322532), received between Mar 9, 2020 and Mar 13, 2026 — classified as 1 injury, 39 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (26 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Mechanics Altered

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED PRIOR TO USE. IT WAS REPORTED THAT THE FLEX ARM CANNOT BE FIXATED. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24597424 ↗
• MalfunctionNov 12, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING MICROENDOSCOPIC DISCECTOMY SPINAL THERAPY. IT WAS REPORTED THAT THE BELLOWS CAME LOOSE DURING THE PROCEDURE. THERE WAS UNKNOWN PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE INSTRUMENT DAMAGED AFTER MANY USES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23530536 ↗
• MalfunctionJul 24, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE RETRACTOR ENGAGEMENT TIP WAS LOOSE. 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 22584947 ↗
• MalfunctionMar 17, 2025Break; Mechanics Altered; Break; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE JOINT FIXING PART BROKEN AND IT HAS COME OFF. 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 21615755 ↗
• MalfunctionDec 6, 2024Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT. IT WAS REPORTED THAT THE SCREW DOES NOT TURN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20862179 ↗
• MalfunctionAug 21, 2024Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT, THE FLEX ARM SCREW WAS LOOSE. THE SCREW WAS LOOSE, SO AN ATTEMPT WAS MADE TO TIGHTEN IT WITH A SCREWDRIVER, ETC., BUT IT DID NOT IMPROVE. 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 20021413 ↗
• MalfunctionMay 7, 2024Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE L-SHAPED FIXED PART DOES NOT TIGHTEN EVEN IF TIGHTENED. 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 19257765 ↗
• MalfunctionApr 25, 2024Mechanical Problem; Mechanical Problem

  2INFORMATION WAS RECEIVED FROM A USER FACILITY (UF) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT USED IN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE CENTRAL PART WAS LOOSE. THERE IS NO PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19179700 ↗
• MalfunctionApr 9, 2024Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING PRIOR TO USE OF REPORTED PRODUCT. IT WAS REPORTED THAT, MOVEMENT ON THE FIXED SIDE OF THE BED WAS STIFF. THERE WAS NO PATIENT INVOLVED DURING THIS EVENT. NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19071641 ↗
• MalfunctionApr 4, 2024Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT BED RAIL COULD NOT FIXED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP THAT WHEN FIXING A JOINT PART, AN ABNORMAL NOISE COULD BE HEARD WHILE TURNING THE PARTS. THIS EVENT HAPPENED DURING PROCEDURE OF MICRO ENDOSCOPIC DISCECTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19039155 ↗
• MalfunctionNov 27, 2023Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT SCREW ON THE BED RAIL CONNECTION PART DID NOT MOVE. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED DUE TO THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP THAT EVENT HAPPENED DURING CONNECTING THE BED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18211233 ↗
• MalfunctionSep 1, 2023Mechanics Altered; Mechanics Altered

  2023-AUG-07 OUS SERVICE AND REPAIR 17443: INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT USED IN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENT DOES NOT BEND. THE PATIENT INVOLVEMENT IN THE EVENT IS UNKNOWN AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT EVENT OCCURRED DURING PROCEDURE AND REPORTED PRODUCT WAS USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17668986 ↗
• MalfunctionJun 30, 2023Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGOING MICROENDOSCOPIC DISCECTOMY (MED) FOR INTERVERTEBRAL DISC HERNIATION. IT WAS REPORTED THAT THE BED RAIL ATTACHMENT HARD EVEN THE SCREW TIGHTENED. PRODUCT CAME IN CONTACT WITH PATIENT. NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTCIPATED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237212 ↗
• MalfunctionJun 23, 2023Mechanical Problem; Mechanical Problem

  MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17189045 ↗
• MalfunctionMay 22, 2023Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH DURING A MED PROCEDURE. IT WAS REPORTED THAT FIXATION WAS NOT POSSIBLE. THERE WAS NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16972533 ↗
• MalfunctionMay 18, 2023Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING PATIENT WITH MED THERAPY. IT WAS REPORTED THAT WHEN THE TIGHTENING SCREW IS TURNED, IT COMES OUT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16951095 ↗
• MalfunctionDec 5, 2022Mechanics Altered; Mechanics Altered

  MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTALS REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15912967 ↗
• MalfunctionNov 24, 2022Mechanics Altered; Mechanics Altered

  MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTALS REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15860314 ↗
• MalfunctionSep 28, 2022Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A BED RAIL ATTACHMENT. IT WAS RE PORTED THAT FIXATION PART OF THE BED RAIL IS HARD. THERE WAS NO PATIENT SYMPTOMS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15500650 ↗
• MalfunctionAug 17, 2022Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A SERVICE AND REPAIR REGARDING A SPINAL PRODUCT USED IN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THERE IS A POOR TIGHTENING. NO FURTHER COMPLICATIONS/SYMPTOMS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT EVENT OCCURRED ON (B)(6) 2022 AND REPORTED PRODUCT CAME IN CONTACT WITH THE PATIENT. PROCEDURE INVOLVED IN THE EVENT IS MICRO ENDOSCOPIC LAMINOPLASTY (MEL).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15238317 ↗
• MalfunctionMay 28, 2022Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING AN INSTRUMENT USED FOR SPINAL SURGERY. PROCEDURE PERFORMED IN THE EVENT WAS MED. IT WAS REPORTED THAT INTRA-OPERATIVELY, THE BED RAIL ATTACHMENT ARM CANNOT BE FIXED. THE PRODUCT CAME IN CONTACT WITH PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14538245 ↗
• MalfunctionMay 24, 2022Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A FLEX ARM AND BED RAIL ATTACHMENT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE SCREW COULD NOT BE TIGHTENED AND COULD NOT BE FIXATED. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT PROCEDURE INVOLVED WAS MED. PRODUCT CAME IN CONTACT WITH PATIENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14489798 ↗
• MalfunctionMar 9, 2022Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH STENOSIS FOR PLIF SPINAL THERAPY. IT WAS REPORTED THAT THE MOVABLE PART AND JOINT PART CAME OFF AND DID NOT RETURN. THERE WAS NO PATIENT SYMPTOM REPORTED. THE PART CAME IN CONTACT WITH THE PATIENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13708456 ↗
• MalfunctionFeb 25, 2022Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A SERVICE AND REPAIR REGARDING A PATIENT FOR AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE BALL JOINT CANNOT BE SECURED. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT REPORTED EVENT HAPPENED ON (B)(6) 2021 DURING PROCEDURE. THE REPORTED PRODUCT CAME IN CONTACT WITH THE PATIENT. THE PROCEDURE INVOLVED IN THE EVENT WAS MICRO ENDOSCOPIC DISCECTOMY (MED) AND PRE-OP DIAGNOSIS WAS SPINAL CANAL STENOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13598687 ↗
• MalfunctionFeb 25, 2022Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING A BED RAIL IN A PLIF FOR A LUMBAR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT DURING THE OPERATION, THE HINGE PART OF THE BED RAIL WAS LOOSE AND WAS DISASSEMBLED AFTER THE OPERATION. THE INSTRUMENT BROKE AND THERE WAS NO FRAGMENT OF THE INSTRUMENT REMAINING IN THE PATIENT'S BODY. THE EVENT WAS ASSOCIATED WITH A PATIENT. IT IS UNKNOWN IF THERE WERE PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THIS PROCEDURE WAS NOT A REVISION SURGERY. IT IS UNKNOWN IF THERE WAS A DELAY IN OVERALL PROCEDURE TIME, IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION NECESSARY, AND TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13596942 ↗