NA 2598-07-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295148128), received between Sep 26, 2019 and Sep 12, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Crack” (5 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.

• MalfunctionSep 12, 2022Crack; Crack

  IT WAS REPORTED THAT THE BLUE COATING ON INSTRUMENT IS STARTING TO PEEL OFF. NOT USED DURING A SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15401278 ↗
• MalfunctionMay 10, 2021Crack; Crack

  MDR STAFF INDICATED THAT THE BLUE COATING ON PRODUCT REF# 259807150 WAS SPLIT. NO SURGICAL DELAY. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11800940 ↗
• MalfunctionApr 21, 2021Crack; Crack

  IT WAS REPORTED THAT THE SALES CONSULTANT RECEIVED A TEXT MESSAGE AND A PHOTO OF ONE OF THEIR CONSIGNMENT INSTRUMENTS (SCIATIC NERVE RETRACTOR) FROM ONE OF THEIR CONSIGNMENT TRAYS (MINIMALLY INVASIVE RETRACTORS). THE BLUE PLASTIC COATING THAT COVERS THE END OF THE RETRACTOR HAD CRACKED OPEN ALONG THE EDGE OF THE RETRACTOR. IT APPEARS FROM THE PHOTO THAT THE PLASTIC COATING IS FULLY INTACT. THE CRACKED COATING WAS DISCOVERED DURING A ROUTINE INSPECTION BY SPD PERSONNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11700116 ↗
• MalfunctionApr 21, 2021Crack; Crack

  IT WAS REPORTED THAT THE SALES CONSULTANT RECEIVED A TEXT MESSAGE AND A PHOTO OF ONE OF THEIR CONSIGNMENT INSTRUMENTS (SCIATIC NERVE RETRACTOR) FROM ONE OF THEIR CONSIGNMENT TRAYS (MINIMALLY INVASIVE RETRACTORS). THE BLUE PLASTIC COATING THAT COVERS THE END OF THE RETRACTOR HAD CRACKED OPEN ALONG THE EDGE OF THE RETRACTOR. IT APPEARS FROM THE PHOTO THAT THE PLASTIC COATING IS FULLY INTACT. THE CRACKED COATING WAS DISCOVERED DURING A ROUTINE INSPECTION BY SPD PERSONNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11700115 ↗
• MalfunctionSep 26, 2019Crack; Crack

  IT WAS REPORTED THAT THE PROTECTION COATING IS PEELING AWAY AND CRACKED. INSTRUMENTS NEED REPLACEMENT. PASSED OFF SURGERY FIELD BEFORE PATIENT WAS IN OPERATION ROOM. NEVER CAME IN CONTACT WITH PATIENT. NO SURGERY DELAY, NO HARM OR NOTHING LEFT IN PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9123427 ↗