ZEVO™ Anterior Cervical Plate System 7713517Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169329294), received between Jan 28, 2019 and Aug 24, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K141632); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO HAD ACDF. IT WAS R EPORTED THAT AT A YEAR OUT FOLLOW UP , BOTH S1 SCREWS WERE BROKEN. 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 17610082 ↗
• MalfunctionJan 5, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT USED IN UNKNOWN S PINAL THERAPY. IT WAS REPORTED THAT THE SCREWS BROKE AT THE C5 LEVEL AND REMAINS IMPLANTED.  PATIENT EXPERIENCING MILD NECK PAIN AT 2 YEAR FOLLOW UP AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT NO REVISION SURGERY SCHEDULED AS OF NOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 16100823 ↗
• InjuryMar 17, 2020Break; Expulsion; Break; Expulsion

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION AT C3-C7, IN WHICH THE PLATE AND SCREWS WERE IMPLANTED. ON AN UNKNOWN DATE, POST-OP, TWO INFERIOR SCREWS AT C7 BACKED OUT. THE LOCKING MECHANISM ON THE C7 SCREWS BROKE AS WELL. HENCE, ON AN UNKNOWN DATE, A REVISION SURGERY WAS PERFORMED, IN WHICH THE ALLEGED SCREWS WERE EXPLANTED. NO FRAGMENT OF THE ALLEGED SCREWS REMAINED INSIDE THE PATIENT. THE PLATE WAS NOT EXPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9843644 ↗
• InjuryMar 17, 2020Break; Expulsion; Break; Expulsion

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION AT C3-C7, IN WHICH THE PLATE AND SCREWS WERE IMPLANTED. ON AN UNKNOWN DATE, POST-OP, TWO INFERIOR SCREWS AT C7 BACKED OUT. THE LOCKING MECHANISM ON THE C7 SCREWS BROKE AS WELL. HENCE, ON AN UNKNOWN DATE, A REVISION SURGERY WAS PERFORMED, IN WHICH THE ALLEGED SCREWS WERE EXPLANTED. NO FRAGMENT OF THE ALLEGED SCREWS REMAINED INSIDE THE PATIENT. THE PLATE WAS NOT EXPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9843512 ↗
• MalfunctionJan 28, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH NON-UNION AND UNDERWENT REVISION SURGERY AT C3-4 LEVELS. DURING SURGERY, THE SCREW BROKE OFF IN HALF WHILE BEING EXPLANTED. THE FRAGMENT OF THE SCREW WAS LEFT IN THE PATIENT BECAUSE IT WAS BURIED IN BONE AND UNABLE TO BE REMOVED. IT WAS REPLACED WITH A NEW SCREW. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; Failure of Implant

  MAUDE report 8280518 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141632. One submission often covers many models, so check the product and lot details in each record.

• Z-1750-2018 · Mar 23, 2018 · Terminated
  Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body