CASPIAN® Spinal System 1101-03516FRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888857012455), received between Nov 12, 2015 and Dec 3, 2019 — classified as 1 injury, 2 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2019Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  A PHYSICIAN REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS A MESA MINI SCREW PLACED AT C5 ON THE RIGHT SIDE WHICH HAD, "COME LOOSE FROM THE PATIENT'S BONE.".

  Patient problems: Injury

  MAUDE report 9403434 ↗
• MalfunctionDec 22, 2016Fracture; Fracture

  ON (B)(6) 2016 IT WAS REPORTED TO K2M, INC. THAT DURING A SURGERY A SCREW WAS DAMAGED DURING LOCKING AND REMAINS IN THE PATIENT. IT WAS ALSO REPORTED THAT EACH OF THE SCREWS IN THE CONSTRUCT WERE SQUEAKING DURING THE LOCKING PROCESS.

  Patient problems: No Information

  MAUDE report 6200227 ↗
• MalfunctionNov 12, 2015Break

  IT WAS REPORTED TO K2M, INC ON 2015-(B)(6) THAT A SURGERY TOOK PLACE IN WHICH THE COLLET OF A CASPIAN SCREW SHEARED OFF DURING PARTIAL LOCKING. THE SCREW WAS LEFT IN THE PATIENT. THIS OCCURRED INTRA-OPERATIVELY ON 2015-(B)(6).

  Patient problems: No Information

  MAUDE report 5219452 ↗