N/A 5330018Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000025199), received between Oct 23, 2019 and Jan 16, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING DEVICES USED FOR POSTERIOR LUMBAR FUSION. IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN. THE DRIVERS WERE STRIPPED. 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 21166036 ↗
• MalfunctionNov 6, 2024Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER. IT WAS REPORTED THAT TIP IS BENT. 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 20618999 ↗
• MalfunctionNov 5, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T10-PELVIS SPINAL THERAPY. THE PATIENT HAD LEG PAIN. IT WAS REPORTED THAT THE TIP OF THE DRIVERS BROKE WHILE PLACING THE SCREWS. THE BENDERS GOT BENT WHILE BENDING THE ROD. THE RODS DID NOT FIT PROPERLY AND NEEDED MORE LORDOSIS. 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 20608185 ↗
• MalfunctionNov 5, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T10-PELVIS SPINAL THERAPY. THE PATIENT HAD LEG PAIN. IT WAS REPORTED THAT THE TIP OF THE DRIVERS BROKE WHILE PLACING THE SCREWS. THE BENDERS GOT BENT WHILE BENDING THE ROD. THE RODS DID NOT FIT PROPERLY AND NEEDED MORE LORDOSIS. 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 20608169 ↗
• MalfunctionMay 20, 2024Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVERS, THORACIC PROBE, ROD HOLDER AND RE TRACTOR USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE HAS BROKEN. 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 19349251 ↗
• MalfunctionJun 30, 2023Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR LUMBAR SPINAL REVISION SURGERY. IT WAS REPORTED THAT THE DRIVER WAS STRIPPED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. 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 17236742 ↗
• MalfunctionFeb 2, 2021Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA FIELD REPRESENTATIVE REGARDING A PATIENT WHO UNDERGONE SPINAL THERAPY WITH AN INDICATION OF ADULT SCOLIOSIS; PSO CORRECTION FOR DEFORMITY. IT WAS REPORTED THAT WHILE PLACING SOLERA MAS INTO A PREVIOUS HOLE, THE PATH WAS VERY HARD BONE. THE SCREWDRIVER STRIPPED WHILE PLACING THE SCREWS. L2-S2 REVISION AND EXTENSION OF PREVIOUS CONSTRUCT. MULTI-LEVEL TLIF WAS PERFORMED. THERE WAS NO DEVICE BREAKAGE. PRODUCT UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. THERE WAS NO SURGICAL DELAY. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11266704 ↗
• MalfunctionOct 23, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO NON-UNION. INTRA-OP, TIP OF THE DRIVER STRIPPED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9222923 ↗