ZEVO™ Anterior Cervical Plate System G7703513Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169398504), received between Jun 27, 2020 and May 8, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Expulsion” (4 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.

• InjuryMay 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A REPEAT SURGERY. THE INITIAL SURGERY WAS A C4-7 CERVICAL SPINE ANTERIOR FUSION SURGERY. IT WAS REPORTED THAT A DV SCREW WAS USED IN C4 (LEFT AND UNKNOWN FOR LEFT/RIGHT BUT PERHAPS RIGHT) AND C7 (RIGHT) FOR EACH OF THEM WITH A FORWARD FIXED ZEVO PLATE. THE DV SCREW AND THE ZV SCREW WERE MISTAKENLY DELIVERED TO NURSES AND WERE INSERTED WITH A ZV SCREWDRIVER. AS A RESULT, ONLY C7 ON THE ZEVO PLATE COULD NOT CLOSE THE LOCKING CAP, AND IT WAS SUGGESTED THAT FOR SEALS, THE SCREW SHOULD BE INSERTED DEEPER OR THE ANGLE (ORBIT) OF THE INSIDE/OUTSIDE SHOULD BE CHANGED. SINCE THE "SCREW LIFTED OFF," THE WOUND CLOSURE/SURGICAL INCISION CLOSURE WAS MADE WITHOUT TURNING THE LOCKING CAP AT THE DOCTOR'S DISCRETION. THE CAUSE MIGHT BE THAT THE DV SCREW WAS USED. THE WOUND CLOSURE/SURGICAL INCISION CLOSURE WAS DONE AND SCREW WAS NOT REPLACED. 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 19266219 ↗
• InjuryJun 27, 2020Expulsion; Expulsion

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CERVICAL SPONDYLOTIC MYELOPATHY; AND UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION AT C4-C6 AND CORPECTOMY WAS PERFORMED AT C5. ON AN UNKNOWN DATE, POST-OP, THE ALLEGED SCREW ALONG WITH 3 MORE SCREWS BACKED-OUT. SINKING OF A TITANIUM MESH IMPLANT WAS ALSO OBSERVED. THE PATIENT SOMETIMES EXPERIENCED RIGHT SHOULDER PAIN AROUND THE TIME WHEN SINKING OF THIS MESH IMPLANT WAS REPORTED. HENCE, THE PATIENT UNDERWENT A REVISION SURGERY, IN WHICH ALL THE 4 BACKED-OUT SCREWS WERE REMOVED AND WERE REPLACED WITH LONGER SCREWS. THE ANTERIOR PLATE (THAT WAS INSERTED IN THE PREVIOUS SURGERY) CAME OFF TOGETHER WITH THE SCREWS AND WAS USED AGAIN BY PERFORMING FIXATION WITH LONGER SCREWS. ALTHOUGH THERE WAS SINKING OF MESH IMPLANT, IT APPEARED TO BE FIT IN ITS POSITION; HENCE, IT WAS NOT REMOVED AND WAS LEFT IMPLANTED IN THE PATIENT'S BODY. "LMS" WAS INSERTED FROM POSTERIOR SIDE INTO C4-C6 AND WAS FASTENED WITH ROD AND CROSSLINK.

  Patient problems: Pain

  MAUDE report 10204283 ↗
• InjuryJun 27, 2020Expulsion; Expulsion

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CERVICAL SPONDYLOTIC MYELOPATHY; AND UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION AT C4-C6 AND CORPECTOMY WAS PERFORMED AT C5. ON AN UNKNOWN DATE, POST-OP, THE ALLEGED SCREW ALONG WITH 3 MORE SCREWS BACKED-OUT. SINKING OF A TITANIUM MESH IMPLANT WAS ALSO OBSERVED. THE PATIENT SOMETIMES EXPERIENCED RIGHT SHOULDER PAIN AROUND THE TIME WHEN SINKING OF THIS MESH IMPLANT WAS REPORTED. HENCE, THE PATIENT UNDERWENT A REVISION SURGERY, IN WHICH ALL THE 4 BACKED-OUT SCREWS WERE REMOVED AND WERE REPLACED WITH LONGER SCREWS. THE ANTERIOR PLATE (THAT WAS INSERTED IN THE PREVIOUS SURGERY) CAME OFF TOGETHER WITH THE SCREWS AND WAS USED AGAIN BY PERFORMING FIXATION WITH LONGER SCREWS. ALTHOUGH THERE WAS SINKING OF MESH IMPLANT, IT APPEARED TO BE FIT IN ITS POSITION; HENCE, IT WAS NOT REMOVED AND WAS LEFT IMPLANTED IN THE PATIENT'S BODY. "LMS" WAS INSERTED FROM POSTERIOR SIDE INTO C4-C6 AND WAS FASTENED WITH ROD AND CROSSLINK.

  Patient problems: Pain

  MAUDE report 10204281 ↗
• InjuryJun 27, 2020Expulsion; Expulsion

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CERVICAL SPONDYLOTIC MYELOPATHY; AND UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION AT C4-C6 AND CORPECTOMY WAS PERFORMED AT C5. ON AN UNKNOWN DATE, POST-OP, THE ALLEGED SCREW ALONG WITH 3 MORE SCREWS BACKED-OUT. SINKING OF A TITANIUM MESH IMPLANT WAS ALSO OBSERVED. THE PATIENT SOMETIMES EXPERIENCED RIGHT SHOULDER PAIN AROUND THE TIME WHEN SINKING OF THIS MESH IMPLANT WAS REPORTED. HENCE, THE PATIENT UNDERWENT A REVISION SURGERY, IN WHICH ALL THE 4 BACKED-OUT SCREWS WERE REMOVED AND WERE REPLACED WITH LONGER SCREWS. THE ANTERIOR PLATE (THAT WAS INSERTED IN THE PREVIOUS SURGERY) CAME OFF TOGETHER WITH THE SCREWS AND WAS USED AGAIN BY PERFORMING FIXATION WITH LONGER SCREWS. ALTHOUGH THERE WAS SINKING OF MESH IMPLANT, IT APPEARED TO BE FIT IN ITS POSITION; HENCE, IT WAS NOT REMOVED AND WAS LEFT IMPLANTED IN THE PATIENT'S BODY. "LMS" WAS INSERTED FROM POSTERIOR SIDE INTO C4-C6 AND WAS FASTENED WITH ROD AND CROSSLINK.

  Patient problems: Pain

  MAUDE report 10204279 ↗
• InjuryJun 27, 2020Expulsion; Expulsion

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CERVICAL SPONDYLOTIC MYELOPATHY; AND UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION AT C4-C6 AND CORPECTOMY WAS PERFORMED AT C5. ON AN UNKNOWN DATE, POST-OP, THE ALLEGED SCREW ALONG WITH 3 MORE SCREWS BACKED-OUT. SINKING OF A TITANIUM MESH IMPLANT WAS ALSO OBSERVED. THE PATIENT SOMETIMES EXPERIENCED RIGHT SHOULDER PAIN AROUND THE TIME WHEN SINKING OF THIS MESH IMPLANT WAS REPORTED. HENCE, THE PATIENT UNDERWENT A REVISION SURGERY, IN WHICH ALL THE 4 BACKED-OUT SCREWS WERE REMOVED AND WERE REPLACED WITH LONGER SCREWS. THE ANTERIOR PLATE (THAT WAS INSERTED IN THE PREVIOUS SURGERY) CAME OFF TOGETHER WITH THE SCREWS AND WAS USED AGAIN BY PERFORMING FIXATION WITH LONGER SCREWS. ALTHOUGH THERE WAS SINKING OF MESH IMPLANT, IT APPEARED TO BE FIT IN ITS POSITION; HENCE, IT WAS NOT REMOVED AND WAS LEFT IMPLANTED IN THE PATIENT'S BODY. "LMS" WAS INSERTED FROM POSTERIOR SIDE INTO C4-C6 AND WAS FASTENED WITH ROD AND CROSSLINK.

  Patient problems: Pain

  MAUDE report 10204277 ↗

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