N/A 9569631Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885074456560), received between Jan 22, 2019 and Jan 21, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING DEVICES USED IN AN UNKNOWN SPI NAL THERAPY. IT WAS REPORTED THAT THE BIPOLAR TIPS DO NOT PROPERLY COME TOGETHER. THE CURETTE TIP BROKE DURING WASHING PROCESS.  DAMAGE WAS DISCOVERED IN SPD.  THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT FOR THE SECOND PRODUCT THE TIPS OF THE BIPOLAR DID NOT COME TOGETHER PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21197075 ↗
• MalfunctionApr 4, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR HERNIATED DISC. IT WAS REPORTED THAT THE TIP BROKE OFF AND WAS REMOVED FROM THE PATIENT. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19039424 ↗
• MalfunctionFeb 26, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF CURETTE WAS LODGED IN DISC SPACE. NO, ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT OF THIS EVENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18775188 ↗
• InjuryJun 6, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A CURETTE USED FOR SPINAL SURGERY. PRE -OPERATIVE DIAGNOSIS WAS HERNIATED DISC COMPRESSING THE NERVE. PROCEDURE PERFORMED IN THE EVENT WAS MIS L4/5 DISCECTOMY. IT WAS REPORTED THAT INTRA-OPERATIVELY, CURETTE WAS BROKEN. THE BROKEN PIECE COULD NOT BE LOCATED DURING THE PROCEDURE. THE CT SCAN WAS COMPLETED TO CONFIRM THAT THE TIP OF THE INSTRUMENT WAS STILL IN THE PATIENT. TIP OF THE BROKEN INSTRUMENT WAS REMOVED IN RE-OPERATION. THE OPERATION TIME FOR THE TIP REMOVAL WAS 2 HOURS. THE REASON FOR THE OPERATION TO TAKE SO LONG WAS TO PERFORM THE EXTRA LEVEL OF DECOMPRESSION TO GET THE TIP OF THE INSTRUMENT OUT FROM PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14603822 ↗
• MalfunctionMay 12, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DISC HERNIATION; AND UNDERWENT MINIMAL INVASIVE SURGERY-DECOMPRESSION AND DISCECTOMY. INTRA-OP, THE INSTRUMENT BROKE. THE SURGEON HAD TO REMOVE MORE DISC THAN NORMAL IN ORDER TO RETRIEVE THE BROKEN PART OF THE INSTRUMENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10047878 ↗
• MalfunctionJan 22, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR RADICULOPATHY AND HERNIATED DISC. DURING SURGERY. THE TIP OF THE INSTRUMENT BROKE OFF. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS OF THE DEVICE ARE REMAINING IN THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8266108 ↗