HelixRecalls & reported problems across all models
Nuvasive, Inc. · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 15 models of Helix by Nuvasive, Inc. in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Dec 20, 2015 and Feb 18, 2025 — classified as 1 injury, 22 malfunctions.
The most frequently reported specific device problem is “Fracture” (6 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Helix problems
Device problems
- Fracture6
- Migration4
- Migration or Expulsion of Device4
- Unintended Movement4
- Detachment of Device or Device Component3
- Malposition of Device2
- Device Damaged by Another Device1
- Material Deformation1
Patient problems
- Failure of Implant14
- No Clinical Signs, Symptoms or Conditions4
- Pain3
- Dysphagia/ Odynophagia1
- Fall1
- No Consequences Or Impact To Patient1
- Perforation of Esophagus1
Helix models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Helix 7803115APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY4 reports
- Helix 7741115APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY3 reports
- Helix 7734117APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- Helix 7803113APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- Helix 7803117APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- Helix 7739215APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- Helix 7740126APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- Helix 7748115APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- Helix 7781240APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- Helix 7781362APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- Helix 7800122APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- Helix 7800236APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- Helix 7800240APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- Helix 7800350APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- Helix 7802215APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
Recent Helix adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 18, 2025Material Deformation; Material Deformation
ON (B)(6) 2025 A PATIENT UNDERWENT A THREE LEVEL ANTERIOR CERVICAL DISCECTOMY FUSION AT C4-C6. IT WAS REPORTED THAT IN A FOLLOW-UP X-RAY IMAGE, THEY DETECTED THAT THREE UPPER SCREWS CAME LOOSE FROM THE PLATE. NO ADVERSE PATIENT SYMPTOMS REPORTED. ON (B)(6), 2025 A REVISION TOOK PLACE WHERE THE PLATE AND SCREWS WERE REMOVED. NO PATIENT INJURY REPORTED NO ADDITIONAL COMPLICATIONS NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21406845 ↗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 ↗MalfunctionJun 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2022 A PATIENT UNDERWENT A CORPECTOMY PROCEDURE AT C4 WITH A FIXATION PLATE C2-C5. POST-OPERATIVELY AT A CHECK-UP ON A SCAN IT WAS NOTED THAT THE PLATE HAS FRACTURED. IT STILL REMAINS IN THE PATIENTS NECK. PATIENT IS ASYMPTOMATIC AND NO REVISION IS PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14704440 ↗MalfunctionJan 24, 2022Migration; Migration
ON (B)(6) 2010 A PATIENT UNDERWENT A ANTERIOR CERVICAL DISCECTOMY FUSION AT C4/5. COMPLAINED SHE HAS BEEN IN PAIN SINCE THE PROCEDURE NO RELIEF. ON (B)(6) 2021 RADIOGRAPHS CONFIRMED THE SUPERIOR SCREW AS BACKED OUT AND A PSEUDOARTHROSIS AT C4/5. PATIENT IS NOW EXPERIENCING LIMITED HEAD MOVEMENT, NECK PAIN, RADICULOPATHY DOWN LEFT SOMETIMES RT ARM, FINGER NUMBNESS LEFT HAND. NO REVISION PLANNED CURRENTLY BEING TREATED WITH MEDICATION AND INJECTION.
Patient problems: Pain
MAUDE report 13335044 ↗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 ↗MalfunctionApr 8, 2020Migration; Migration
ON (B)(6) 2020 A PATIENT UNDERWENT A SPINAL PROCEDURE FROM THE C5-C7 LEVELS. DURING A ROUTINE POST-OP FOLLOW UP IT WAS DISCOVERED VIA XRAY THAT MULTIPLE SCREWS HAD PULLED OUT THROUGH THE IMPLANTED PLATE AT THE C5 AND C6 LEVELS. AS PER REPORTER PRE THE DISCOVERY THE PATIENT WAS ASYMPTOMATIC. PATIENT UNDERWENT A REVISION PROCEDURE TO REMOVE HARDWARE AND NO ADDITIONAL CONSTRUCT WAS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 9936598 ↗MalfunctionApr 6, 2020Migration; Migration
A PATIENT UNDERWENT A CERVICAL SPINAL FUSION PROCEDURE AT C4-C7 LEVELS ON (B)(6) 2020. TWO WEEKS POSTOPERATIVELY, RADIOGRAPHS REVEALED A SCREW HAD BACKED-OUT OF THE PLATE. NO REVISION PROCEDURE HAS BEEN SCHEDULED AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 9931052 ↗MalfunctionApr 1, 2020Migration; Migration
PATIENT UNDERWENT A CERVICAL SPINAL FUSION PROCEDURE AT C5-C7 LEVELS ON (B)(6) 2020. AS PER REPORTER APROXIMATELY ONE MONTH POSTOPERATIVELY, RADIOGRAPHS REVEALED A SCREW HAD BACKED-OUT OF THE PLATE. NO REVISION PROCEDURE IS PLANNED AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 9914511 ↗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 ↗MalfunctionDec 17, 2018Fracture; Fracture
ON (B)(6) 2018 PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY FUSION FROM C3-C6 LEVELS WITH NO REPORTED COMPLICATIONS. ON (B)(6) 2018 THE PATIENT FELT A POP AND RESIDUAL PAIN, RADIOGRAPHS SHOWED A FRACTURED SCREW AT THE LEFT SIDE OF C6 LEVEL. THE SURGEON NOTED FUSION HAD BEEN ACHIEVED AND NO REVISION WILL BE PERFORMED.
Patient problems: Pain
MAUDE report 8169578 ↗MalfunctionSep 5, 2018No Apparent Adverse Event; No Apparent Adverse Event
PATIENT UNDERWENT A C5 LEVEL CORPECTOMY WITH A NON NUVASIVE CAGE AND A HELIX-T PLATE ON (B)(6) 2018. REPORTEDLY, THE PATIENT SUFFERED A FALL FIVE DAYS POST-SURGERY AND UNDERWENT A REVISION PROCEDURE DUE TO A BROKEN PLATE. NO CAGE DISLODGING NOR FRACTURES TO THE VERTEBRAL BODY OR SCREWS WERE NOTED.
Patient problems: Fall
MAUDE report 7846215 ↗MalfunctionAug 29, 2018Unintended Movement; Unintended Movement
ON (B)(6) 2018 PATIENT UNDERWENT A CERVICAL PROCEDURE WHERE A HELIX R PLATE WAS IMPLANTED. POST-OPERATIVE SURGEON IDENTIFIED TWO UPPER SCREWS BACK OUT. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2018 WHERE PLATE WAS REPLACED. NO PATIENT INJURY HAS BEEN REPORTED.
Patient problems: Failure of Implant
MAUDE report 7825594 ↗MalfunctionAug 6, 2018Unintended Movement; Unintended Movement
RECEIVED INFORMATION STATING PATIENT WAS EXPERIENCING A SCREW BACK OUT 11 WEEKS POSTOPERATIVE. AT THIS TIME THERE IS NO REVISION PROCEDURE SCHEDULED NOR PATIENT INJURY REPORTED.
Patient problems: Failure of Implant
MAUDE report 7754435 ↗MalfunctionJul 27, 2017Migration or Expulsion of Device; Unintended Movement; Migration or Expulsion of Device; Unintended Movement
ON (B)(6) 2017 PATIENT UNDERWENT A REVISION SURGERY DUE TO HELIX SCREW BACKOUT. PATIENT WAS REPORTED TO HAVE NO ISSUES POST SURGERY.
Patient problems: Failure of Implant
MAUDE report 6748522 ↗
Other Nuvasive, Inc. products
All Nuvasive, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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