N/A 7756195Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994207999), received between Jun 21, 2018 and Jun 21, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Device Slipped” (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 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.

• InjuryJun 21, 2018Device Slipped; Device Slipped

  PRE-OPERATIVE DIAGNOSIS: CERVICAL SPONDYLOTIC MYELOPATHY DUE TO SYMPTOMATIC RECURRENCE. TYPE OF PROCEDURE: POSTERIOR CERVICAL DECOMPRESSION AND FUSION WITH DURAL SUTURE. IT WAS REPORTED THAT INTRA-OPERATIVELY WHEN THE PEDICAL SCREW WAS INSERTED IN C7 THROUGH CT NAVIGATION IT WAS OBSERVED WITH THE HELP OF C-ARM THAT IT WAS PENETRATING THE END PLATE OF CRANIAL SIDE AT C7 AND DEVIATED FROM PEDICAL SCREW. DUE TO WHICH THE SCREW DRIVER SLID AND TOUCHED THE DURA AND INJURY OF THE DURA OCCURRED. THEREAFTER ADDITIONAL SURGERY DURAL SUTURE WAS PERFORMED, SO THE SCREW WAS REMOVED. WHILE INSERTING THE SCREW AFTER DECOMPRESSION. A CRACK OCCURRED IN THE ARCH OF VERTEBRA. DUE TO WHICH THE SCREW WAS NOT INSERTED. THE SURGERY WAS DELAYED BY LESS THAN 60 MINUTE DUE TO THIS EVENT. BOTH THE IMPLANTS DID NOT COME IN CONTACT WITH THE PATIENT. NO BREAKAGE OF IMPLANTS OCCURRED DUE TO REPORTED EVENT. NO FRAGMENTS OF INSTRUMENTS WERE REMAINED IN PATIENT. PATIENT COMPLICATIONS WERE UNKNOWN WITH THE AVAILABLE INFORMATION. THE TIP OF THE DRIVER DID NOT FIT WITH THE SCREW AND SLIPPED DUE TO WHICH DURA INJURED AND DURAL SUTURE WAS PERFORMED.

  Patient problems: Bone Fracture(s)

  MAUDE report 7624947 ↗