TSPACE PEEK/XP SN305RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964479137), received between Feb 10, 2022 and Feb 9, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2023Unintended System Motion; Unintended System Motion

  INVESTIGATION COMPLETE.

  Patient problems: Laceration(s)

  MAUDE report 16340375 ↗
• InjuryFeb 10, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO AESCULAP AG THAT A TSPACE PEEK/XP INSERTION INSTRUMENT (PART # SN305R) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, A METAL SHEATH HAS FALLEN OFF DURING SURGERY. INSERTS FOR T-SPACE WORK WITHOUT PROBLEMS DURING THE OPERATION. SUBSEQUENTLY DURING CLEANING OF INSTRUMENT, IT IS FOUND THAT ONE METAL CAP IS MISSING . A WELD WAS BROKEN AND THE METAL SHEATH HAS FALLEN OFF. CANNOT BE FOUND DESPITE INTENSE SEARCH. X-RAYS POSTOPERATIVELY SHOWED THE METAL SHEATH WAS NOT PRESENT WITHIN PATIENT. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13509341 ↗