mambo™ modular cervical plate system CS 1830-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04052536008346), received between Apr 7, 2017 and Apr 7, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionApr 7, 2017Break; Break

  INITIAL SURGERY WAS FOR SEVERE MYELOPATHY WITH CORD SPINAL CHANGE AT C4/5 AND C5/6. POST OPERATIVE X-RAYS REVEALED SCREW BREAKAGE OCCURRED IN (B)(6) 2013, BUT BECAUSE OF THE PATIENT'S LACK OF PAIN AND HER GENERAL MEDICAL CONDITION, SHE AND THE SURGEON DECIDED NOT TO REVISE UNLESS NECK PAIN DEVELOPED. SHE WAS IN A CAR ACCIDENT IN (B)(6) 2014 AND DEVELOPED NECK PAIN AFTERWARDS, BUT WAS NOT OFFERED SURGERY AT THE TIME BASED ON HER MEDICAL CONDITION. PATIENT PRESENTED IN (B)(6) 2016 WITH A NEW STENOSIS AT C3/4 AND IN (B)(6) 2016 RECEIVED SURGERY TO ADDRESS THIS. DURING THIS SURGERY, THE SURGEON IDENTIFIED THAT ALL OF THE MAMBO SCREWS INCLUDING THE BROKEN ONE WERE SOLIDLY FUSED, SO THEY WERE LEFT IN PLACE. TO ADDRESS THE NEW STENOSIS AT C3/4, THE SURGEON IMPLANTED A POSTERIOR SCREW/ROD SYSTEM WITH LAMINECTOMY. HE LAST SAW THE PATIENT ON (B)(6) 2017 AND SHE REPORTED THAT NECK PAIN WAS RESOLVED AND MYELOPATHIC SYMPTOMS WERE IMPROVING.

  Patient problems: Failure of Implant

  MAUDE report 6471617 ↗