LITe PEDICLE BASED RETRACTOR 48760631CRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327135473), received between Nov 8, 2016 and Aug 10, 2020 — classified as 3 malfunctions.

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

• MalfunctionAug 10, 2020Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT THE SECURING MECHANISM OF A LITE PEDICLE BASE RETRACTOR MEDIAL ARM ASSEMBLY WAS "SPINNING IN THE VOID" INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10385032 ↗
• MalfunctionDec 27, 2016Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT THE MEDIAL ARM BROKE DURING SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6205913 ↗
• MalfunctionNov 8, 2016Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; MEDIAL ARM OF RETRACTOR BROKE AND RENDERED USELESS. "PULLING" MECHANISM OF MEDIAL ARM SCREW BROKE AND MADE THE ARM UNABLE TO LOCK IN PLACE WHEN RETRACTED MEDIALLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6087094 ↗