na 9569565Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885074451206), received between Oct 17, 2018 and Sep 29, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LEFT LUMBAR MIC RODISCECTOMY. IT WAS REPORTED THAT THE JAW BROKE WHEN DOCTOR WAS ON DISC AND A PIECE HAD FALLEN INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED AND FOLLOWED WITH AN X-RAY. EVERYTHING WAS GOOD. 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 15507496 ↗
• MalfunctionJul 12, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ROUTINE MICRODI SCECTOMY FOR DISC HERNIATION. IT WAS REPORTED THAT THE 2MM PITUITARY BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT WAS LEFT IN 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 14983734 ↗
• MalfunctionFeb 14, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT SPINAL THERAPY FOR PRO LAPSED INTERVERTEBRAL DISC (PID). IT WAS REPORTED THAT THE PRODUCT WAS BROKEN. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCT CAME IN CONTACT WITH THE PATIENT AND NO BROKEN FRAGMENTS WERE LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13520563 ↗
• MalfunctionAug 10, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH UNKNOWN INDICATION INVOLVED IN MICRO DISC L5-1. IT WAS REPORTED THAT DURING PROCEDURE, THE INSTRUMENT BROKE AND NO FRAGMENTS LEFT IN THE PATIENT'S BODY. PRODUCT WAS UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT OF THIS EVENT. PATIENT IS ALIVE AND NO INJURY. ON 2021-AUG-20, RECEIVED ADDITIONAL INFORMATION THAT INSTRUMENT BROKE INTO 2 PIECES. THERE WAS NOT MUCH DELAY, HAD SWITCHED THE INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12299954 ↗
• MalfunctionJun 9, 2021Difficult to Open or Close; Physical Resistance/Sticking; Difficult to Open or Close; Physical Resistance/Sticking

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA FIELD REPRESENTATIVE REGARDING A PATIENT WHO UNDERGONE SPINAL THERAPY WITH AN INDICATION OF RADICULOPATHY. IT WAS REPORTED THAT DURING MIS DISCECTOMY THE SCISSORS WERE DEEMED DULL BY THE CONSUMER AND THE MICRO PITUITARY DIDN¿T OPEN AND CLOSE LIKE IT SHOULD. ADDITIONALLY, IT WAS MENTIONED THAT THE INSTRUMENTS NOT CUTTING/TOO DULL. IT WAS UNKNOWN WHETHER THE DEVICE WAS BROKEN OR NOT. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. PRODUCT UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED. IT WAS REPORTED THAT NO CUTTING ISSUES WITH THE MICRO PITUITARY. THE ISSUE WITH THAT INSTRUMENT WAS THAT IT WAS STICKING AND NOT GRABBING PROPERLY. NOTHING BROKE AND NOTHING LEFT IN PATIENT. THERE WAS NO MAJOR SURGICAL DELAY. THIS PRODUCT SET HAS BEEN IN ROTATION FOR SEVERAL MONTHS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11964001 ↗
• MalfunctionOct 17, 2018Break; Break

  PROCEDURE: MINIMALLY INVASIVE DISCECTOMY PRE OPERATIVE DIAGNOSIS: HERNIATED DISC IT WAS REPORTED THAT INTRA-OP, HANDLE OF THE PRODUCT BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE PRODUCT REMAINED IN THE PATIENT BODY. NO PATIENT SYMPTOM AND COMPLICATION WERE REPORTED AT THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7975976 ↗