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ORTHROS ORO-7540RRecalls & reported problems

Camber Spine Technologies, LLC · Ø7.5mm polyaxial reduction pedicle screw , 40mm lg. · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B030ORO7540R0), received between Jan 8, 2018 and Jan 8, 2018 — classified as 1 malfunction.

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

  • Fracture1

Patient problems

  • Arthritis1

Recent adverse event reports

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

  • MalfunctionJan 8, 2018Fracture

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL LAMINECTOMY FOR DECOMPRESSION AT L4-S1 AND X-RAY SHOWED HARDWARE FRACTURE (2 REDUCTION SCREWS) WITH PSEUDOARTHROSIS AT L5-S1 APPROXIMATELY 6-7 MONTHS POSTOP.

    Patient problems: Arthritis

    MAUDE report 7172457 ↗

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