ZEVO™ Anterior Cervical Plate System 7713513Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169329256), received between Feb 20, 2017 and Apr 22, 2024 — classified as 1 injury, 7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2024Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) FOR A TWO LEVEL C3-5 WITH A C5-7 PLATE REMOVAL OF OLD ALPHATEC HARDWARE. IT WAS REPORTED THAT PLATE HAS BACKED OFF THE ANTERIOR PORTION OF THE CERVICAL SPINE. ADDITIONAL SURGERY NEEDED, COMING BACK ON (B)(6) 2024 TO REMOVE THE CERVICAL PLATE THAT HAS BACKED OUT. PATIENT HAD PAIN AND TROUBLE SWALLOWING. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. IMPLANT DATE WAS RECORDED IN THE ORIGINAL REPORT AS 10/10/23. ADDITIONAL INFORMATION RECEIVED FROM THE REP THAT THE ALLEGATIONS WERE MADE AGAINST THE ENTIRE SYSTEM DUE TO THE FACT THAT THE ENTIRE PLATE PULLED OUT OF THE PATIENT¿S BONE. COMMENTS CONSISTED OF THE DIAMETER OF THE SCREW BEING SMALLER MIGHT HAVE CREATED MORE OF AN ISSUE WHEN COMPARED TO A PLATE WITH A LARGER DIAMETER SCREW.

  Patient problems: Dysphagia/ Odynophagia; Pain

  MAUDE report 19151492 ↗
• MalfunctionFeb 21, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW IN A PREVIOUS SURGERY. IT WAS REPORTED THAT THERE WAS SCREW LOOSENING AT THE HCP'S 6-WEEK POST OP APPOINTMENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THERE WAS NO ADDITIONAL SURGERY OR TREATMENT/ REVISION SURGERY/ DELAY IN OVERALL PROCEDURE TIME/ HOSPITALIZATION NECESSARY AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13567223 ↗
• MalfunctionJan 24, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ACDF AT C4-C7 S PINAL THERAPY FOR ANTERIOR DISCECTOMY. IT WAS REPORTED THAT THE SCREW BROKE AT THE PROXIMAL END JUST BELOW THE HEAD.  FRAGMENT REMAINS IN THE PATIENT. SECOND PIECE WAS DISCARDED OF. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13339641 ↗
• MalfunctionNov 11, 2021Material Fragmentation; Material Fragmentation

  INFORMATION WAS RECEIVED FROM A COMPETENT AUTHORITY (DECLARATION NUMBER (B)(4)) & HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH THE SCREWS & PLATES WITH ANTERIOR CERVICAL FIXATION THERAPY. IT WAS REPORTED THAT THE SURGEON SCREWED AND UNSCREWED THE SCREWS SEVERAL TIMES THROUGH THE PLATE AND CHANGED SIZES. AS A RESULT, A STEEL WOOL APPEARED. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12791938 ↗
• MalfunctionJun 10, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DEGENERATIVE CERVICAL DISC DISEASE; AND UNDERWENT ANTERIOR CERVICAL ARTHRODESIS. INTRA-OP, THE SCREW BROKE WHILE SCREWING IN. NO FRAGMENT OF THE BROKEN SCREW REMAINED INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10141507 ↗
• MalfunctionJul 10, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT PRESENTED WITH PRE-OP DIAGNOSIS AS: CERVICAL STENOSIS. FOR WHICH PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY WITH FUSION (ACDF) PROCEDURE. INTRA-OP, SCREW WAS BROKEN. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE IMPLANT REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6699665 ↗
• MalfunctionFeb 20, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) REVISION SURGERY DUE TO PRE-OP DIAGNOSIS OF CERVICAL STENOSIS AT FOUR LEVELS. INTRA-OP, SCREWS HEAD SHEARED OFF. SURGEON REMOVED THE PLATE AND PERFORMED ACDF AT THE LEVEL ABOVE AND BELOW THE PREVIOUS FUSION. WHEN SURGEON WAS IMPLANTING THE C6 SCREWS, SURGEON THINK THAT THE SCREWS MADE CONTACT WITH THE PEEK CAGE FROM THE PREVIOUS SURGERY AND HENCE THE HEADS SHEARED OFF. THE REMAINDER OF THE SCREW WAS LEFT IN THE BODY AND THE LOCKING CAP OF THE CERVICAL PLATE WAS CLOSED OVER IT. THE HOSPITAL KEPT THE SHEARED OFF PORTIONS OF THE SCREW HEAD. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6344596 ↗
• MalfunctionFeb 20, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) REVISION SURGERY DUE TO PRE-OP DIAGNOSIS OF CERVICAL STENOSIS AT FOUR LEVELS. INTRA-OP, SCREWS HEAD SHEARED OFF. SURGEON REMOVED THE PLATE AND PERFORMED ACDF AT THE LEVEL ABOVE AND BELOW THE PREVIOUS FUSION. WHEN SURGEON WAS IMPLANTING THE C6 SCREWS, SURGEON THINK THAT THE SCREWS MADE CONTACT WITH THE PEEK CAGE FROM THE PREVIOUS SURGERY AND HENCE THE HEADS SHEARED OFF. THE REMAINDER OF THE SCREW WAS LEFT IN THE BODY AND THE LOCKING CAP OF THE CERVICAL PLATE WAS CLOSED OVER IT. THE HOSPITAL KEPT THE SHEARED OFF PORTIONS OF THE SCREW HEAD. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6344595 ↗

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