SPROTTE® 041151-30ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14048223000516), received between Nov 7, 2017 and Aug 23, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2018Fracture; Material Split, Cut or Torn; Fracture; Material Split, Cut or Torn

  (B)(4). DATE OF EVENT UNKNOWN. BREAKAGE OF NEEDLE.

  Patient problems: Device Embedded In Tissue or Plaque; Pain

  MAUDE report 7808034 ↗
• InjuryNov 7, 2017Break; Fracture; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Device Handling Problem; Break; Fracture; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Device Handling Problem

  (B)(4). DATE OF EVENT UNKNOWN. TOOK PLACE IN (B)(6) AND HAS BEEN REPORTED TO TGA. FROM INITIAL REPORTER¿S NARRATIVE: DOCTOR WAS UNAWARE NEEDLE HAD BROKEN OFF, SO CAN'T COMMENT ON WHETHER OCCURRED ON INSERTION OR REMOVAL 4 ATTEMPTS AT LP, 3 NEEDLES USED - 24G X 3 BROKEN-OFF FRAGMENT WAS FOUND WHEN PATIENT RETURNED AS AN OUTPATIENT TO HAVE A FLUOROSCOPIC-GUIDED LP 5 DAYS LATER- IT WAS SEEN ON THE SCOUT FILM. THE PATIENT WAS THEN ADMITTED THROUGH ED AND HAD THE 65MM FRAGMENT REMOVED BY THE NEUROSURGERY TEAM 6 DAYS AFTER THE INITIAL LP. ON THE DAY OF DISCHARGE FROM HOSPITAL THERE HAD BEEN NO ADVERSE OUTCOME RECORDED, ASIDE FROM SURGERY (NO NEUROLOGICAL DEFICIT, NO INFECTION) THE HOSPITAL REPORT IS NOT FINALISED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7005450 ↗