na 9569567Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885074451220), received between Jul 17, 2018 and Apr 23, 2024 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE SPINE SURGERY. IT WAS REPORTED THAT INSTRUMENT HANDLE BROKE. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19161564 ↗
• MalfunctionJan 11, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN T RANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE WAS BROKEN DURING SURGERY. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490718 ↗
• MalfunctionFeb 9, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING TRANSFORAMINAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT THE PITUITARY ROUNGER BROKE DURING PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS OF RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16331826 ↗
• MalfunctionDec 8, 2021Break; Break

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PATIENT UNDERGOING MICRODISCECTOMY PROCEDURE. THE PRE-OP DIAGNOSIS WAS MENTIONED AS M51.26 LEFT L5-S1 HERNIATED DISC. IT WAS REPORTED THAT, THE PIECE THAT BROKE WAS LEFT IN THE PATIENT. TWO MICRO PITUITARIES BROKE DURING THE PROCEDURE AND BOTH TIPS WERE LEFT IN THE PATIENT. SURGEON DECIDED THAT TRYING TO REMOVE THE PIECE COULD CAUSE MORE DAMAGE THAN LEAVING IT IN THE PATIENT. THERE WERE NO SYMPTOMS TO PATIENT OR PHYSICIAN WERE REPORTED. THERE WAS NO ADDITIONAL SURGERY OR TREATMENT PERFORMED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12959483 ↗
• MalfunctionDec 8, 2021Break; Break

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PATIENT UNDERGOING MICRODISCECTOMY PROCEDURE. THE PRE-OP DIAGNOSIS WAS MENTIONED AS M51.26 LEFT L5-S1 HERNIATED DISC. IT WAS REPORTED THAT, THE PIECE THAT BROKE WAS LEFT IN THE PATIENT. TWO MICRO PITUITARIES BROKE DURING THE PROCEDURE AND BOTH TIPS WERE LEFT IN THE PATIENT. SURGEON DECIDED THAT TRYING TO REMOVE THE PIECE COULD CAUSE MORE DAMAGE THAN LEAVING IT IN THE PATIENT. THERE WERE NO SYMPTOMS TO PATIENT OR PHYSICIAN WERE REPORTED. THERE WAS NO ADDITIONAL SURGERY OR TREATMENT PERFORMED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12959465 ↗
• MalfunctionOct 12, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING AN INSTRUMENT USED FOR MICRODISCECTOMY THERAPY. IT WAS REPORTED THAT DURING THE DISCECTOMY THE INSTRUMENT GOT DAMAGE. THERE WAS NO PATIENT INVOLVED IN THE EVENT. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THE EVENT WAS HAPPENED AT THE TIME OF SURGERY ONLY. WHEN THE INSTRUMENT SUDDENLY STOPPED WORKING THAN SURGEON NOTICED THAT THE TIP WAS BROKEN. SURGEON TRIED TO FIND THAT BROKEN PIECE FIRST INTO THE PATIENT THROUGH INTRA-OP CARM SCANS OR RADIOLOGIC IMAGES BUT COULD NOT FIND ANYTHING IN THE PATIENT. PATIENT IS ABSOLUTELY FINE <(>&<)> SAFE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12611939 ↗
• MalfunctionJul 22, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING PATIENT SPINAL THERAPY FOR LUMBAR RADICULOPATHY. IT WAS REPORTED THAT THE 2MM UPBITING PITUITARY BROKE DURING NORMAL USE. 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. NO ISSUES WITH THE PATIENT INVOLVEMENT. THE PATIENT WAS NOT HARMED DUE TO THE DEVICE BREAKING. THE PATIENT IS DOING FINE. THE DEVICE BROKE DUE TO NORMAL WEAR AND TEAR. THIS EVENT HAPPENED INTRA OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12208509 ↗
• MalfunctionJun 16, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH L5/S1 MICRODISC THERAPY. IT WAS REPORTED THAT DURING USE THE PITUITARY SNAPPED. X-RAY CONFIRMED THAT 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 12006223 ↗
• MalfunctionOct 21, 2020Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A MICROPITUITARY. IT WAS REPORTED THAT INSTRUMENT BROKE WHILE TRYING TO GRIP INTERVERTEBRAL DISC. RELEASE HANDLE BROKE OFF OF INSTRUMENT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 10710169 ↗
• InjuryJul 17, 2018Break; Fracture; Break

  IT WAS REPORTED THAT ON: (B)(6) 2017: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH L3-L4, L4-L5 DISK HERNIATION. LUMBAR RADICULOPATHY AND UNDERWENT THE FOLLOWING PROCEDURES: RIGHT L3-L4 AND L4-L5 MICRODISECTOMY. APPLICATION OF 80 MG OF TOPICAL DEPO-MEDROL EPIDURAL STEROID. USE OF C-ARM FLUOROSCOPY. USE OF OPERATING MICROSCOPE. COMPLICATIONS: FRACTURED PITUITARY RONGEUR INTO L4-5 DISK SPACE. INTRAOPERATIVE HYPOTENSION. (B)(6) 2017: THE PATIENT UNDERWENT THE CT OF ABDOMEN/ PELVIS. IMPRESSION: TRAUMATIC INJURY CAUSING PSEUDOANEURYSM OF THE RIGHT COMMON ILIAC ARTERY AND FISTULA BETWEEN THE RIGHT COMMON ILIAC ARTERY AND IVC. RETROPERITONEAL HEMATOMA. ON (B)(6) 2017: THE PATIENT UNDERWENT CT ANGIOGRAM OF PELVIS ABDOMEN. IMPRESSION: CONTINUED FOCAL EXTRAVASATION/PSEUDOANEURYSM OF THE PROXIMAL RIGHT ILIAC ARTERY WITH RAPID PASSAGE INTO THE VENOUS SYSTEM HEADING IN THE VENA CAVA. THE SIZE OF THE CURRENT PSEUDOANEURYSM/FOCUS OF EXTRAVASATION IS SLIGHTLY SMALLER THAN EARLIER EXAMINATION. INCREASING RETROPERITONEAL AND PELVIC HAEMATOMA. ON (B)(6) 2017: THE PATIENT WAS DIAGNOSED WITH IVC THROMBUS. RETROPERITONEAL HEMATOMA. ILLIAC ARTERY EXTRAVASATION. ON (B)(6) 2017: THE PATIENT UNDERWENT CT

  Patient problems: Coagulation Disorder; Device Embedded In Tissue or Plaque; Embolism/Embolus; Embolus; Encephalopathy; Extravasation; Fistula; Hematoma; Low Blood Pressure/ Hypotension; Neuropathy; Pain

  MAUDE report 7693131 ↗