SPROTTE 041251-29ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048223104316), received between Jun 21, 2021 and Jul 2, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. 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.

• InjuryJul 2, 2025Break; Break

  IRN# (B)(4). INCIDENT OCCURRED IN ITALY: WHILE REMOVING THE NEEDLE TO CHANGE POSITION, IT BROKE AND THE STUMP REMAINED INSIDE THE PATIENT, IMPOSSIBLE TO REMOVE WITH BARE HANDS (ABOUT 4.5CM). THEREFORE, THE PATIENT REQUIRED A DIAGNOSTIC-THERAPEUTIC PATHWAY, WHICH ENDED WITH THE REMOVAL OF THE STUMP BY THE NEUROSURGERY COLLEAGUES. NO NEUROLOGICAL DAMAGE WAS REPORTED IN THE PATIENT THROUGHOUT THE PERIPROCEDURAL PATHWAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22381699 ↗
• InjuryJul 26, 2022Fracture; Fracture

  IRN-# 191-22_761. EVENT TOOK PLACE IN FRANCE, TENTATIVE TRANSLATION OF INITIAL REPORTER´S NARRATIVE: DURING A LUMBAR PUNCTURE, THE NEEDLE BROKE IN THE PATIENT'S BACK. ON REMOVAL, A PORTION REMAINED IN THE SUBCUTANEOUS TISSUE. USUAL LUMBAR PUNCTURE TECHNIQUE (USE OF INTRODUCTER AND STILET IN THE NEEDLE DURING REMOVAL) OVERWEIGHT PAEDIATRIC PATIENT 137 KG. ADMITTED TO THE NEUROSURGERY UNIT ON 22 JUNE FOR PLACEMENT OF A VENTRICULO-ATRIAL SHUNT AND REMOVAL OF THE NEEDLE FRAGMENT. INFECTION OF THE SHUNT LEADING TO RE-HOSPITALIZATION OF THE PATIENT WITH REMOVAL OF THE SHUNT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15101393 ↗
• MalfunctionJun 21, 2021Break; Fracture; Break; Fracture

  IRN# (B)(4). TENTATIVE SUMMARIZING TRANSLATION FROM INITIAL REPORTER´S NARRATIVE: "DURING SEVERAL ATTEMPTS TO PLACE THE NEEDLE IN THE SPINAL SPACE AT L2-L3 (AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO PLACE IT IN L3-L4) THE NEEDLE BROKE AT 3 CM DURING THE REMOVAL PROCEDURE OF THE NEEDLE WITH ITS INTRODUCER. DURING THE PROCEDURE I HAD NEVER CSF FLOW THROUGH THE NEEDLE AND WE HAD NO PARESTESIA. AT THE END THE PATIENT MOVES THE LEGS WITHOUT ANY SENSITIVE OR PHISICAL PROBLEMS. WE CALLED THE SURGEON TO TRY TO SURGICALLY REMOVE THE TIP OF THE NEEDLE WITH LOCAL ANESTHESIA AND SEDATION, AFTER TALKING TO THE PATIENT. FINALLY WE SUCCEDED IN REMOVING THE NEEDLE".

  Patient problems: Foreign Body In Patient

  MAUDE report 12030751 ↗