n/a 2941608Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994352415), received between Jul 16, 2020 and Jul 4, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 4, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT AN UNKNOWN SPINAL THERAPY FOR DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT WHEN SURGEON WAS ROTATING THE SHAVER IN A COLLAPSE DISC SPACE, THE SHAVER BLADE TWISTED OFF AND BROKEN. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCT CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14902887 ↗
• MalfunctionMay 31, 2021Material Fragmentation; Material Fragmentation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PADDLE SHAVER USED IN OBLIQUE LATERAL INTERBODY FUSION OF L3 / 4 / 5. IT WAS REPORTED THAT AFTER OLIF OF L3 / 4 WAS PERFORMED, OLIF WAS PERFORMED AT L4 / 5. L4 / 5 HAD A SMALL DISK SPACE AND IT WAS DIFFICULT TO ROTATE THE SHAVER. WHEN ATTEMPTED TO ROTATE IT FORCIBLY, THE SHAVER BROKE OFF. THE TIP OF THE BROKEN OFF SHAVER LEFT BETWEEN THE VERTEBRAL BODIES, BUT IT HAD BEEN COLLECTED USING A FORCEPS, AND THERE WAS NO PROBLEM WITH THE PATIENT. NO FRAGMENTS LEFT IN PATIENT BODY. A DISTRACTOR WAS USED TO FINISH THE PROCEDURE. NO PATIENT SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11906870 ↗
• MalfunctionJul 16, 2020Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH SCOLIOSIS FOR SPINAL THERAPY. IT WAS REPORTED THE EVENT OCCURRED INTRA-OP, THE 8MM SHAVER BROKE OFF AT THE TIP. THE FRAGMENT WAS REMOVED FROM THE PATIENT. THE 10 AND 12 BOTH WERE BENT. NO FRAGMENTS LEFT IN PATIENT. NO FURTHER SYMPTOMS REPORTED IN PATIENT. DEVICE STATUS: WILL BE RETURNED; REPLACED WITH OTHER MANUFACTURER'S PRODUCT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10281802 ↗