ZEVO Anterior Cervical Plate SystemRecalls & reported problems across all models
Medtronic Sofamor Danek, Inc. · 39 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 83
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls
- 1
We found 39 models of ZEVO Anterior Cervical Plate System by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 83 adverse event reports in the FDA's MAUDE database, received between Feb 20, 2017 and Aug 6, 2025 — classified as 38 injuries, 45 malfunctions.
The most frequently reported specific device problem is “Break” (31 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
ZEVO Anterior Cervical Plate System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 23, 2018Class IITerminated
Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm.
Z-1750-2018 · Root cause: Process control · Recall details · FDA record ↗
Most reported ZEVO Anterior Cervical Plate System problems
Device problems
- Break31
- Migration14
- Device Dislodged or Dislocated7
- Loosening of Implant Not Related to Bone-Ingrowth7
- Expulsion6
- Mechanics Altered6
- Migration or Expulsion of Device5
- Material Fragmentation4
Patient problems
- No Clinical Signs, Symptoms or Conditions30
- Pain20
- No Known Impact Or Consequence To Patient16
- Device Embedded In Tissue or Plaque6
- Failure of Implant5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Discomfort3
- No Consequences Or Impact To Patient3
ZEVO Anterior Cervical Plate System models
39 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ZEVO™ Anterior Cervical Plate System 7710015APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- ZEVO™ Anterior Cervical Plate System 7713515APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY13 reports
- ZEVO™ Anterior Cervical Plate System 7713513APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY8 reports
- ZEVO™ Anterior Cervical Plate System 7713517APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY5 reports
- ZEVO™ Anterior Cervical Plate System G7703513APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY5 reports
- ZEVO™ Anterior Cervical Plate System G7783513APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY4 reports
- ZEVO™ Anterior Cervical Plate System 7714013APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY3 reports
- ZEVO™ Anterior Cervical Plate System G7703515APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY3 reports
- ZEVO™ Anterior Cervical Plate System G7723513APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY3 reports
- ZEVO™ Anterior Cervical Plate System G3003055APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- ZEVO™ Anterior Cervical Plate System G3002041APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- ZEVO™ Anterior Cervical Plate System 7723513APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- ZEVO™ Anterior Cervical Plate System 7723515APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- ZEVO™ Anterior Cervical Plate System 7724015APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- ZEVO™ Anterior Cervical Plate System 7713518APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- ZEVO™ Anterior Cervical Plate System 3001017APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- ZEVO™ Anterior Cervical Plate System G7783515APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- ZEVO™ Anterior Cervical Plate System G3003061APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ZEVO™ Anterior Cervical Plate System G3003063APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ZEVO™ Anterior Cervical Plate System G3001019APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ZEVO™ Anterior Cervical Plate System G3001021APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ZEVO™ Anterior Cervical Plate System G3002037APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ZEVO™ Anterior Cervical Plate System G7724015APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ZEVO™ Anterior Cervical Plate System 7723517APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ZEVO™ Anterior Cervical Plate System 7724017APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ZEVO™ Anterior Cervical Plate System 7714015APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ZEVO™ Anterior Cervical Plate System 3003063APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ZEVO™ Anterior Cervical Plate System 3003057APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ZEVO™ Anterior Cervical Plate System 3001015APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ZEVO™ Anterior Cervical Plate System 3001027APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ZEVO™ Anterior Cervical Plate System 3002029APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ZEVO™ Anterior Cervical Plate System 3002033APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ZEVO™ Anterior Cervical Plate System 3002035APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ZEVO™ Anterior Cervical Plate System 3002037APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ZEVO™ Anterior Cervical Plate System 3003055APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ZEVO™ Anterior Cervical Plate System 3004078APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ZEVO™ Anterior Cervical Plate System 7713515Appliance, fixation, spinal intervertebral body1 report
- ZEVO™ Anterior Cervical Plate System G7713515APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- ZEVO™ Anterior Cervical Plate System G7713513APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
Recent ZEVO Anterior Cervical Plate System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING PATIENT HAVING SPINAL THERAPY FOR CERVICAL SPONDYLOTIC MYELOPATHY. IT WAS REPORTED THAT DURING THE SURGERY; THE SCREW LOCKING ISSUE OCCURRED. THE 90° SET SCREW WAS ROTATED, BUT IT TURNED ONCE BECAME LOOSE AND DID NOT STOP. THE SCREW AND PLATE WERE REMOVED AND REINSERTED. THERE WAS A DELAY OF LESS THAN 60 MINUTES AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22724767 ↗MalfunctionJun 13, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DURING THE IMPLANTATION OF A SCREW INTO THE VERTEBRAL BODY, THE SCREW SNAPPED IN HALF. HALF OF THE SCREW REMAINED EMBEDDED IN THE BONE AND COULD NOT BE REMOVED, WHILE THE OTHER HALF WAS SUCCESSFULLY EXTRACTED. IT WAS NOTED THAT THERE WAS NO HIGH TORQUE OR FORCE APPLIED TO THE SCREW DURING THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22203177 ↗MalfunctionFeb 4, 2025Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT UNDERGOING ANTERIOR CERVICAL DISCECTOMY WITH FUSION (ACDF). IT WAS REPORTED THAT THE ZEVO PLATE WAS BROKEN DURING PROCEDURE. NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED DUE TO THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP THAT PRE OPERATIVE DIAGNOSIS OF THIS EVENT WAS CERVICAL DEGENERATIVE DISC DISEASE. NO FRAGMENTS LEFT INSIDE THE PATIENT AND NO REVISION SURGERY PLANNED/HAPPENED DUE TO THIS EVENT. PATIENT HAD MEDICAL HISTORY OF CERVICAL RADICULOPATHY AND MYELOPATHY AS WELL , POWER IN THE UPPER LIMBS WAS 3/5.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21301379 ↗MalfunctionJan 29, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A ACDF CERVICAL FIXATION PROCEDURE. SCREW REMAINS IN THE PATIENT. PROCEDURE WAS AT C4/C5 - C5/C6 ¿ C6/C7 LEVEL. PATIENT HAD 3 DISCECT OMIES. IT WAS REPORTED THAT THE SCREW BROKE DURING IMPLANTATION. WHERE THE SCREW IS BROKEN, IT WAS IMPOSSIBLE TO REPLACE A NEW SCREW. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21263717 ↗MalfunctionJan 25, 2025Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A SCREW USED IN ANTERIOR CERVICAL DISCECTOMY AND FUSION THERAPY. IT WAS REPORTED THAT THE SCREW HEAD BROKE OFF FROM THE SHAFT UPON INSERTION. THE SHANK OF THE SCREW REMAINED IN THE VERTEBRAL BODY, UNABLE TO BACK OUT ONCE THE HEAD OF THE SCREW SHEARED OFF FROM THE SHANK DURING IMPLANTATION. IT WAS A NORMAL APPROACH TO PLACING SCREWS. AWL WAS USED TO CREATE PILOT HOLE FOR THE SCREW. THIS WAS THE FIFTH SCREW GOING IN OF EIGHT TOTAL. THE HEAD OF THE SCREW SHEARED OFF FROM THE SHANK WHEN ADVANCING THE SCREW THROUGH THE SCREW HOLE IN THE PLATE AND INTO THE VERTEBRAL BODY. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21236283 ↗MalfunctionJan 9, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH SCREW. IT WAS REPORTED THAT DURING POST OP FOLLOW UP APPOINTMENT IT WAS OBSERVED THAT THE SELF TAPPING SCREW BACKED OUT BY 1-2 THREADS. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WAS NO ADDITIONAL/REVISION SURGERY PERFORMED OR PLANNED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21109001 ↗MalfunctionJan 5, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE. IT WAS REPORTED THAT THE PLATE BROKE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21075958 ↗MalfunctionJan 3, 2025Migration; Migration
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR CERVICAL FUSION FOR CERVICAL SPONDYLOTIC MYELOPATHY. IT WAS REPORTED THAT ON JULY 7, THE ZV WASINITIALLY USED. LESS THAN 3 WEEKS AFTER THE SURGERY, DISLODGEMENT (MIGRATION) OF THE BONE GRAFT WAS OBSERVED. COMPARATIVE IMAGES OF POSTOPERATIVE AND MOST RECENT X-RAY IMAGING WERE OBTAINED. THE GRAFTED BONE COLLAPSED 20¿30° POSTERIORLY. AS A RESULT, THE L4 LOWERENDPLATE - THE L6 UPPER ENDPLATE WILL DECREASE BY 4-5 MM, AND THE C6 SCREW ANGLE WILL BE -10° (IT WAS BELIEVED THAT THE VARIABLE MECHANISM WAS ACTIVATED). THE PATIENT RECEIVED AN ILIAC BONE GRAFT FOR THE C5 CORPECTOMY AND PLATE FIXATION FOR THE C4-6. THE GENERAL FLOW OF THE PROCEDURE IS AS FOLLOWS: DEPLOYMENT WITH A PIN DISTRACTOR, ILIAC BONE GRAFTING, AND FIXATION WITH A PLATE. SINCE IT WASFIX-GROUP, THE GRAFTED BONE WAS MORE FIRM THAN LOOSE; IT WAS SLIGHTLY TAPPED AND INSERTED DURING THE ILIAC GRAFT. WHEN DISTRACTION WAS LOOSENED AND CHECKED, THERE WAS NO FEELING OF MOVEMENT, AND IT WAS STEADY. THE VERTEBRAL ENDPLATE WAS ALSO NOT DISRUPTED. NO SINKING WAS OBSERVED, AND IT SEEMED LIKE IT HAD DISLODGED BEHI
Patient problems: Pain
MAUDE report 21065363 ↗MalfunctionJan 2, 2025Migration; Migration
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT, TWO OF THE SUPERIOR SCREWS AND ONE OF THE INFERIOR SCREWS WERE BACKING OUT. IT WAS NOTED AT 6 WEEK PATIENT POST OP REVIEW. PATIENT DISPLAYED SIGNS OF DYSPRAXIA. NO FURTHER COMPLICATIONS REPORTED AS A RESULT.
Patient problems: Unspecified Nervous System Problem
MAUDE report 21052432 ↗MalfunctionJan 2, 2025Migration; Migration
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT, TWO OF THE SUPERIOR SCREWS AND ONE OF THE INFERIOR SCREWS WERE BACKING OUT. IT WAS NOTED AT 6 WEEK PATIENT POST OP REVIEW. PATIENT DISPLAYED SIGNS OF DYSPRAXIA. NO FURTHER COMPLICATIONS REPORTED AS A RESULT.
Patient problems: Unspecified Nervous System Problem
MAUDE report 21052419 ↗MalfunctionJan 2, 2025Migration; Migration
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT, TWO OF THE SUPERIOR SCREWS AND ONE OF THE INFERIOR SCREWS WERE BACKING OUT. IT WAS NOTED AT 6 WEEK PATIENT POST OP REVIEW. PATIENT DISPLAYED SIGNS OF DYSPRAXIA. NO FURTHER COMPLICATIONS REPORTED AS A RESULT.
Patient problems: Unspecified Nervous System Problem
MAUDE report 21052357 ↗MalfunctionNov 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE SPINAL THERAPY. IT WAS REPORTED THAT SCREW AT C3 ON THE PATIENTS LEFT SIDE APPEARED TO HAVE BACKED OUT AFTER FLIPPING THE PATIENT FOR THE POSTERIOR PROCEDURE. THE SCREW HAD BACK OUT SLIGHTLY AND WAS OUTSIDE THE LOCK MECHANISM AND THE LOCK MECHANISM AT THE TOP AND MIDDLE OF THE PLATE WERE ONLY PARTIALLY LOCKED. THE SURGEON ADVANCED THE SCREW AND LOCKED THE MECHANISMS. PHYSICIANS COMMENTED THAT THE PATIENT HAD POOR BONE QUALITY. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20724419 ↗MalfunctionNov 19, 2024Migration; Migration
INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE SPINAL THERAPY. IT WAS REPORTED THAT SCREW AT C3 ON THE PATIENTS LEFT SIDE APPEARED TO HAVE BACKED OUT AFTER FLIPPING THE PATIENT FOR THE POSTERIOR PROCEDURE.THE SCREW HAD BACK OUT SLIGHTLY AND WAS OUTSIDE THE LOCK MECHANISM AND THE LOCK MECHANISM AT THE TOP AND MIDDLE OF THE PLATE WERE ONLY PARTIALLY LOCKED. THE SURGEON ADVANCED THE SCREW AND LOCKED THE MECHANISMS. PHYSICIANS COMMENTED THAT THE PATIENT HAD POOR BONE QUALITY. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20724216 ↗MalfunctionNov 1, 2024Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR CERVICAL DISCECTOMY AND FUSION THERAPY FOR CERVICAL STENOSIS. LEVELS IMPLANTED WAS C3-6. IT WAS REPORTED THAT SURGEON STRUGGLED WITH LOCKING ZEVO PLATES AFTER PLACING SCREWS AS THE LOCKING MECHANISMS BROKE OFF WHEN HE ATTEMPTED TO LOCK THE PLATE. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20587805 ↗MalfunctionNov 1, 2024Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR CERVICAL DISCECTOMY AND FUSION THERAPY FOR CERVICAL STENOSIS. LEVELS IMPLANTED WAS C3-6. IT WAS REPORTED THAT SURGEON STRUGGLED WITH LOCKING ZEVO PLATES AFTER PLACING SCREWS AS THE LOCKING MECHANISMS BROKE OFF WHEN HE ATTEMPTED TO LOCK THE PLATE. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20587600 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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