Helix 7741115Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517096784), received between Sep 23, 2021 and Mar 28, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (2 reports).

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.

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.

• MalfunctionMar 28, 2024Device Damaged by Another Device; Device Damaged by Another Device

  ON (B)(6) 2021 A PATIENT UNDERWENT A C5/6 ANTERIOR CERVICAL DISCECTOMY, BILATERAL C6 FORAMINOTOMY, AND FUSION AND PLATING PROCEDURE, UTILIZING A MODULUS-C INTERBODY AND A HELIX MINI PLATE WITH HELIX MINI SCREWS, TO ADDRESS BILATERAL C6 RADICULOPATHY, THERE WERE NO NOTED COMPLICATIONS DURING THIS PROCEDURE. IT WAS REPORTED THE PATIENT SUBSEQUENTLY EXPERIENCED ONGOING PAIN WITH SUSPECTED NON-UNION AND IT WAS LATER DISCOVERED THAT ONE OF THE SCREWS HAD LOST FIXATION. ON (B)(6) 2022 A REVISION SURGERY WAS PERFORMED WHERE THE PLATE, SCREWS, AND INTERBODY WERE REMOVED. AFTER REMOVAL, IT WAS NOTED ONE OF THE SCREWS WAS MISSING ITS COLLAR COMPONENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 18996259 ↗
• MalfunctionSep 23, 2021Malposition of Device; Malposition of Device

  ON (B)(6) 2021 A PATIENT UNDERWENT A SPINAL PROCEDURE ON UNKNOWN LEVELS OF THE SPINE. ON (B)(6) 2021 IT WAS DISCOVERED THAT DURING A ROUTINE FOLLOW UP THAT AN IMPLANTED SCREW ADVANCED THROUGH THE CANTED COIL LOCKING MECHANISM OF AN IMPLANTED PLATE AND INTO THE VERTEBRAL BODY. THE PATIENT IN ASYMPTOMATIC AND NO REVISION IS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12522561 ↗
• MalfunctionSep 23, 2021Malposition of Device; Malposition of Device

  ON (B)(6) 2021 A PATIENT UNDERWENT A AN ANTERIOR CERVICAL DISCECTOMY PROCEDURE ON UNKNOWN LEVELS OF THE SPINE. ON A UNKNOWN DATE IT WAS DISCOVERED DURING A ROUTINE FOLLOW UP THAT A IMPLANTED SCREW ADVANCED THROUGH THE CANTED COIL LOCKING MECHANISM OF AN IMPLANTED PLATE AND INTO THE VERTEBRAL BODY. THE PATIENT IS ASYMPTOMATIC AND NO ADVERSE CONSEQUENCES WERE REPORTED. A REVISION OCCURRED ON SEPTEMBER (B)(6) 2021 WHERE THE DEVICE WAS REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12522367 ↗