Helix 7803115Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887517138934), received between Mar 4, 2016 and May 29, 2019 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2019Fracture; Migration or Expulsion of Device; Fracture; Migration or Expulsion of Device

  ON (B)(6) 2017 A PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY FUSION PROCEDURE C3-6 WITHOUT A REPORTED ISSUE. ON (B)(6) 2018 FOLLOW UP RADIOGRAPHS SHOWED A FRACTURED SCREW. ON (B)(6) 2018 FOLLOW UP RADIOGRAPHS SHOWED 3 FRACTURED SCREWS AND 2 OF THEM BACKED OUT. NO REPORTED PATIENT PAIN OR INJURY. NO REVISION PERFORMED TO DATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8652492 ↗
• MalfunctionFeb 22, 2017Fracture; Fracture

  ON (B)(6) 2014 A (B)(6) YEAR OLD MALE PATIENT UNDERWENT A 3-LEVEL PROCEDURE ON C4 TO C7. TWENTY FOUR MONTHS POST-OP IT WAS DISCOVERED THAT ONE OF THE PROXIMAL SCREWS FRACTURED AND WAS BEGINNING TO BACK OUT OF THE PLATE. NO PATIENT INJURY HAS BEEN REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 6351770 ↗
• MalfunctionApr 12, 2016Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement

  IN (B)(6) 2014 A (B)(6) FEMALE UNDERWENT A THREE LEVEL ACP SURGERY AT C3-C6. NO TRAUMA OR INJURY WAS CONFIRMED. PATIENT DID NOT COMPLAIN OF PAIN BUT RADIOGRAPH CONFIRMED THAT THE SCREW HAD BACKED OUT. REVISION SURGERY TOOK PLACE ON (B)(6) 2016.

  Patient problems: Failure of Implant

  MAUDE report 5572039 ↗
• InjuryMar 4, 2016Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  ON (B)(6) 2016 A (B)(6) YEAR-OLD MALE UNDERWENT A REVISION PROCEDURE DUE TO ADJACENT SEGMENT DEGENERATION WITH THE GOAL OF EXTENDING THE FUSION CONSTRUCT FROM THE ORIGINAL C5-C7 TO INCLUDE C3-C4 LEVELS. DURING EVALUATION IT WAS NOTED THAT A SCREW IMPLANTED IN THE C7 VERTEBRAL BODY HAD LOOSENED AND BACKED OUT. FOLLOWING WHAT WAS REPORTED TO BE A SMOOTH SURGERY, THE PATIENT DEVELOPED SUBCUTANEOUS EMPHYSEMA SECONDARY TO ESOPHAGEAL PERFORATION. THE PERFORATION WAS REPAIRED (B)(6) 2016.

  Patient problems: Dysphagia/ Odynophagia; Failure of Implant; Perforation of Esophagus

  MAUDE report 5481796 ↗