Orthros MIS ORM-35CRecalls & reported problems
Camber Spine Technologies, LLC · Ø5.5mm Curved Rod 35mm Lg. · Class 2 · Implant
- 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 B030ORM35C0), received between Sep 16, 2024 and Sep 16, 2024 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- Implant Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2024Fracture; Fracture
ON (B)(6) 2024 A 62 YEAR OLD MALE PATIENT HAD GONE THROUGH SURGERY DURING WHICH TWO ORTHORS MIS RODS (ORM-35C) WERE IMPLANTED. AS PER PATIENT DESCRIPTION WHEN HE WAS DOING DISHES WHILE LOADING/UNLOADING DISHWASHER, HE HEARD A LOUD POP IN HIS BACK. THE PATIENT FELT SOME PAIN AND KNEW SOMETHING WAS WRONG. PATIENT MADE A FOLLOW UP APPOINTMENT AND WAS SEEN IN OFFICE ON (B)(6) 2024 IN THE MORNING. UPON X-RAYING PATIENT IT WAS DISCOVERED THAT BOTH 35MM RODS WERE BROKEN. A REVISION SURGERY WAS SCHEDULED ON (B)(6) 2024. DURING THE REVISION SURGERY THE ORTHROS MIS RODS WERE EXPLANTED ALONG WITH THE PEDICLE SCREW AND ITS RESPECTIVE SET SCREWS. NEW ORTHROS MIS RODS ALONG WITH NEW PEDICLE SCREWS AND SET SCREWS WERE IMPLANTED. THE PATIENT IS NO LONGER FEELING PAIN POST SURGERY.
Patient problems: Implant Pain
MAUDE report 20224647 ↗
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- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.