N/A 7480100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00721902760303), received between Apr 13, 2020 and Jun 29, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2021Break; Break

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PATIENT UNDERGOING A PROCEDURE OF T10-PELVIS INSTRUMENTED FUSION. THE PRE-OPERATIVE DIAGNOSIS WAS MENTIONED AS ADULT SCOLIOSIS OF THE LUMBAR SPINE. IT WAS REPORTED THAT DUAL ENDED PROBE, THE SURGEON REMOVED THE INSTRUMENT AFTER FEELING THE CANNULA CREATED PRIOR TO PLACING A PEDICLE SCREW AND NOTICED THE BALL END WAS MISSING. UPON X-RAYS TAKEN IN THE ROOM, NOTICED THE METALLIC METAL PIECE LEFT IN THE PATIENT. THEY WERE ABLE TO SUCTION THAT ITEM OUT AND REPLACED THE INSTRUMENT WITH ANOTHER PROBE FOR THE REMAINDER OF THE PROCEDURE. THE TIP WAS BROKEN ABOUT 10MM OFF AND THE BROKEN PART WAS RETRIEVED SUCCESSFULLY. THERE WAS A DELAY OF ABOUT 30 MINUTES REPORTED AND MENTIONED DELAY WAS DUE TO THE BROKEN INSTRUMENT. ALL THE REPORTED PRODUCTS CAME IN CONTACT WITH PATIENT. THERE WERE NO SYMPTOMS TO PATIENT OR PHYSICIAN WERE REPORTED. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12082418 ↗
• InjuryJan 19, 2021Break; Break

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA MANUFACTURER REPRESENTATIVE FOR AN EVENT WHICH OCCURRED DURING POSTERIOR LUMBAR TLIF SURGERY ON A PATIENT DIAGNOSED WITH LUMBAR DISC HERNIATION. IT WAS REPORTED THAT THE PROBE BROKE IN THE PATIENT DURING THE NORMAL USE OF THE PROBE IN THE SURGERY. IN ORDER TO REMOVE THE PROBE, MORE PEDICLES NEEDED TO BE DEALT WITH IN ORDER TO REMOVE THE BROKEN PROBE IN THE PATIENT. THE OPERATION TIME WAS EXTENDED BY ONE AND A HALF HOURS WHILE REMOVING MORE BONE, AND THE DOCTOR¿S EXPOSURE TIME TO X-RAYS INCREASED BY ONE AND A HALF HOURS. PRODUCT WILL BE RETURNED, AND IT WAS REPLACED WITH MEDTRONIC PRODUCT. NO OTHER PATIENT INJURY / COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11192296 ↗
• InjuryApr 13, 2020Break; Break

  IT WAS REPORTED THAT INTRA-OP, WHILE THE SOUNDING FEELER PROBE WAS BEING USED IN THE VERTEBRAL BODY, THE TIP OF THE INSTRUMENT BROKE AND WAS LEFT INSIDE THE VERTEBRAL BODY. X-RAY WAS DONE TO CONFIRM THE EXACT LOCATION OF THE BROKEN TIP OF THE INSTRUMENT. THE RESULTS OF THIS X-RAY ARE UNKNOWN CURRENTLY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9953725 ↗