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General instrumentation IG007RRecalls & reported problems

LDR Spine Usa, Inc. · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03662663002523), received between Apr 25, 2022 and Apr 25, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Dislodged or Dislocated1

Patient problems

  • Numbness1
  • Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT A RETRACTOR COULD NOT BE LOCKED DURING SURGERY. IT MOVED OUT AND AWAY FROM THE DISC SPACE, CAUSING A LOSS OF DISTRACTION SO THAT FIRM HAMMERING WAS NEEDED TO INSTALL THE IMPLANT. AFTER THE PROCEDURE, THE PATIENT HAD PAIN IN THEIR NECK AND NUMBNESS IN THEIR FINGERS, WHICH IS DISAPPEARING SLOWLY.

    Patient problems: Numbness; Pain

    MAUDE report 14197241 ↗

Other Retractor devices

All Retractor devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.