n/a 2940075Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994120120), received between Jul 4, 2020 and Dec 4, 2023 — classified as 5 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR T10 /ILIAC ANTERIOR L1/5 OLIF THERAPY FOR DEGENERATIVE SCOLIOSIS. IT WAS REPORTED THAT THE SCREW ON THE TIP OF THE SHAFT WAS TAKEN OUT IN THE SURGICAL FIELD. SCREW CAME OFF. IT SEEMED IT WAS BROKEN DURING OP. AS IT CAME OFF IN THE SURGICAL FIELD, THERE WAS CONTACT WITH THE PATIENT. THERE WAS A DELAY OF AROUND LESS THAN 60 MINUTES. THERE WAS NO EXTENSION OF HOSPITALIZATION AND NO ADDITIONAL SURGERY OCCURRED IN THIS EVENT. 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 18254394 ↗
• MalfunctionMay 18, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH LUMBAR STENOSIS FOR SPINAL THERAPY. IT WAS REPORTED THAT THE PITUITARY BROKE DURING PROCEDURE. THERE WERE NO FRAGMENTS OF THE IMPLANTS OR INSTRUMENTS REMAINED IN THE PATIENT'S BODY. PRODUCT WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PRODUCT CAME IN CONTACT WITH THE PATIENT. DEVICE BROKE WHILE USING THE INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11839520 ↗
• MalfunctionJan 29, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA FIELD REPRESENTATIVE REGARDING A PATIENT WHO UNDERGONE SPINAL THERAPY WITH AN INDICATION OF ADJACENT LEVEL FUSION. IT WAS REPORTED THAT DEVICES WERE BROKEN, AND NO FRAGMENT OF THE DEVICE REMAINS IN PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO ADDITIONAL SURGERY OR TREATMENT PERFORMED AS A RESULT OF THIS EVENT. SURGICAL DELAY WAS ABOUT 7-10 MINUTES WHILE THE BROKEN TIP RETRIEVED FROM INSIDE OF THE IMPLANT. PRODUCT CAME IN CONTACT WITH PATIENT AS IT BROKEN WHILE IMPLANT. PRODUCT UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11249910 ↗
• MalfunctionJul 13, 2020Component Missing; Component Missing

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA FIELD CONTACT REGARDING A PATIENT WITH A PRE-OPERATIVE DIAGNOSIS OF SPINAL CANAL STENOSIS, UNDERGOING AN OLIF PROCEDURE FOR A SPINAL THERAPY. IT WAS REPORTED THAT, FROM THE BEGINNING, THERE WAS NO SOCKET SET SCREW ON THE CONNECTING PART BETWEEN THE REPORTED RONGEUR HANDLE AND THE SHAFT. OLIF WAS PERFORMED AT L2/5. THE REPORTED PRODUCT WAS NOT USED BECAUSE THE EVENT WAS NOTICED BEFORE THE REPORTED PRODUCT WAS USED. THE DOCTOR DID NOT FIND ANY OBJECTS LIKE THE SCREW AROUND, SO THE PROCEDURE WAS CONTINUED AND FINALLY THE IMAGE WAS CHECKED AND CONFIRMED THAT THERE WERE NO FOREIGN OBJECTS REMAINING IN THE PATIENT¿S BODY. THE INSTRUMENT HAD BEEN PREPARED WITH BEING PUT IN A HOSPITAL BASKET. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS A DELAY OF LESS THAN 60 MINS IN THE OVERALL PROCEDURE TIME. ADDITIONAL COMMENTS ABOUT THE EVENT STATED THAT, AS FOR THE REASON OF THIS EVENT, THERE WERE DOUBTS ABOUT THE PROCESS FROM DELIVERY TO THE HOSPITAL TO WASHING, BUT IT WAS STRICTLY POINTED OUT FOR QUALITY CHECKS SUCH AS SCREW LOOSENING AND DROPPING DUE TO VIBRATION REQUIRED FOR ROUTINE CLEANING AND CA

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

  MAUDE report 10263228 ↗
• MalfunctionJul 4, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH STENOSIS FOR LUMBAR DECOMPRESSION. IT WAS REPORTED THAT THE PITUITARY BROKE DURING PROCEDURE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WERE NO FRAGMENTS OF THE IMPLANT OR INSTRUMENT REMAINING IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10230828 ↗