Avenue L EC019RRecalls & reported problems
LDR Spine Usa, Inc. · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03662663036399), received between Mar 23, 2021 and Dec 22, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
Device problems
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 22, 2021Fracture; Fracture
IT WAS REPORTED THE CLAMP'S KNOB ON AN ARTICULATING ARM AND THE CENTER ARM ON A FIXATION PIN BROKE DURING SURGERY. THERE WERE NO PATIENT IMPACTS REPORTED, BUT THE PROCEDURE WAS DELAYED WHILE THE CLAMP WAS REASSEMBLED AND THE BROKEN ARM FROM THE PIN WAS RECOVERED. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13060473 ↗MalfunctionMar 23, 2021Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF A RETRACTOR PIN BROKE DURING SURGERY. THERE WAS NO REPORTED PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11555209 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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