Kiva KIV2200Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813478020025), received between Sep 30, 2015 and Sep 30, 2015 — classified as 1 injury.

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

Recent adverse event reports

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

• InjurySep 30, 2015Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS FILED TO REPORT A RE-FRACTURE AT THE TREATED LEVEL OBSERVED 21 DAYS POST PROCEDURE, WHICH SUBSEQUENTLY REQUIRED SURGICAL INTERVENTION. THE T6 LEVEL WAS TREATED WITH KIVA VIA THE LEFT PEDICLE WITH ABOUT 2 LOOPS OF IMPLANT AND 1CC OF CEMENT VOLUME. THERE WERE NO ISSUES WITH THE DEVICE, AND NO PATIENT COMPLICATION WAS REPORTED DURING THE KIVA PROCEDURE. THE PROCEDURE WAS CONSIDERED UNEVENTFUL AND SUCCESSFUL BY THE TREATING PHYSICIAN. THE PATIENT WAS RELEASED THEREAFTER AND INDICATED PAIN IMPROVEMENT ON THE FIRST PHONE FOLLOW-UP APPROXIMATELY ONE WEEK POST KIVA PROCEDURE. 21 DAYS POST PROCEDURE ON (B)(6) 2015, THE PATIENT CAME BACK WITH BACK PAIN AND CT IMAGING IDENTIFIED A RE-FRACTURE AT THE INDEX LEVEL, WHICH WAS TREATED ACCORDINGLY WITH PAIN MEDICATION, AND SUBSEQUENTLY RELEASED. LATE AUGUST/EARLY (B)(6), THE PATIENT CAME BACK TO THE HOSPITAL, NOW UNABLE TO MOVE HER LEGS AND HAD LITTLE SENSATION IN THEM. UPON FURTHER CT IMAGING, THE INDEX LEVEL SUFFERED AN APPARENT BURST FRACTURE. EVIDENCE OF BONE REABSORPTION FROM LUCENCY SURROUNDING THE IMPLANT WAS SEEN, AS MENTIONED BY THE PHYSICIAN. THE PATIENT UNDERWENT AN UNCOMPLICATED DECOMPRESSION PROCEDURE ON (B)(6) 2015 TO PR

  Patient problems: Bone Fracture(s); Pain; Paralysis

  MAUDE report 5115547 ↗