na 9569536Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885074451183), received between Jun 29, 2021 and Nov 23, 2023 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 23, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT L3/4 LEVEL. IT WAS REPORTED THAT THE DEVICE WAS BROKEN. NO FRAGMENTS OF THE DEVICE WERE REMAINING IN THE PATIENT. 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 18197135 ↗
• MalfunctionJan 27, 2022Break; Break

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A TLIF PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN AND DID NOT TORQUE. NO PATIENT INJURY/ COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13364460 ↗
• MalfunctionOct 11, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING PITUITARY IN A L4/L5 WILTSE NAVIGATED TLIF FOR AN L4/L5 TLIF. IT WAS REPORTED THAT THE PITUITARY BROKE DURING USE AND THERE WAS NO FRAGMENT OF THE INSTRUMENT REMAINING IN THE PATIENT'S BODY. INSTRUMENT BROKE IN PLANNED DEGENERATIVE SPINE SURGERY. THE DAMAGED INSTRUMENT DID NOT INFLUENCE THE SURGERY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THE PRODUCT WAS USED IN OPERATION FIELD AND PATIENT CAME IN CONTACT WITH REPORTED PRODUCT. THERE WAS NO ADDITIONAL SURGERY OR TREATMENT/ REVISION SURGERY/ DELAY IN OVERALL PROCEDURE TIME/ HOSPITALIZATION NECESSARY AS A RESULT OF THIS EVENT. THERE WAS NO FURTHER IMPACT FROM THE INCIDENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12604435 ↗
• MalfunctionJun 29, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR SPINAL STENOSIS (PROCEDURE PERFORMED WAS MIS DECOMPRESSION). IT WAS REPORTED THAT THE PITUITARY WAS BROKEN AT THE TIP. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12081980 ↗