ZEVO™ Anterior Cervical Plate System 7713515 (UDI 00643169329270)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169329270), received between May 1, 2019 and Jan 29, 2025 — classified as 7 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionMar 16, 2024Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING DEVICES USED FOR ACDF C6/7. IT WAS REPORTED THAT THE SURGEON NOTICED THE SCREW WAS BACKING OUT OF HIS PATIENT. HE USED A POST OPERATIVE CT. PATIENT SYMPTOMS ARE UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18918928 ↗
• MalfunctionMar 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A TDR AT 3/4 ACDF AT 5/6. IT WAS REPORTED THAT THE SCREW IS BACKING OUT OF THE PLATE. THERE WAS NO PATIENT SYMPTOM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18854560 ↗
• MalfunctionMar 17, 2022Loosening 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 AN EVENT WHICH OCCURRED DURING A ACDF PROCEDURE IN A PATIENT DIAGNOSED WITH CERVICAL SPINE ISSUES. IT WAS REPORTED THAT THE SCREW WAS LOOSENING. THE SCREW LOOSENING WAS OBSERVED AT THE PATIENT'S POST OP APPOINTMENT ABOUT 6 WEEKS AFTER THE SURGERY. NO REVISION PROCEDURE IS SCHEDULED. THERE WAS NO PATIENT SYMPTOM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13796791 ↗
• InjuryDec 16, 2021Break; Break

  THE INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT FOR SPINAL FUSION THER APY WITH CERVICAL SPONDY, CERVICAL RADICULITIS, CERVICAL SPINAL STENOSIS, FORMER SMOKER (QUIT 1999), NO ALCOHOL USE, BMI 25-29.9. IT WAS REPORTED THAT SCREW WAS BROKEN AND APPROXIMATELY HALF OF THE SCREW WAS REMOVED FROM LEFT C7. THREE-LEVEL FUSION WAS PERFORMED ON (B)(6) 2019. CORNERSTONE LASR GRAFTS WERE PLACED AT C4/C5, C5/C6, C6/C7. A 55MM 3-LEVEL ZEVO PLATE WAS THEN PLACED ANTERIOR FROM C4-C7. PATIENT DID WELL POST OP. SURGICAL HISTORY: APPENDECTOMY HYSTERECTOMY TONSILLECTOMY CERVICAL SPINE SURGERY ¿ REMOVAL OF BROKEN SCREW AT C6-7. HYSTERECTOMY LIGATION OF FALLOPIAN TUBE CERVICAL SPINE SURGERY ¿ (B)(6) 2020 ¿ C3-C4 ACDF CERVICAL SPINE SURGERY ¿ (B)(6) 2019 ON (B)(6) 2022: INDICATION: POST-MENOPAUSAL WOMAN WITH OSTEOPENIA. FINDING: DUAL X-RAY ABSORPTIOMETRY IS PERFORMED OF THE LUMBAR SPINE AND LEFT PROXIMAL FEMUR. IMPRESSION: OSTEOPENIA OF THE LUMBAR SPINE AND LEFT FEMORAL NECK. ON (B)(6) ¿ 2022: FINDING: HEART SIZE AND MEDIASTINAL CONTOURS ARE WITH IN NORMAL ARE WITHIN NORMAL LIMITS. NO PULMONARY INFILTRATES, EDEMA, OR MASSES. NO PLEURAL EFFUSIO

  Patient problems: Pain

  MAUDE report 13015992 ↗
• 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 12791933 ↗
• InjurySep 23, 2021Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (PATIENT, MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WITH STENOSIS DEGENERATIVE DISC DISEASE FOR ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SPINAL THERAPY AT C3-C6. IT WAS REPORTED THAT THE ZEVO LOCKING MECHANISM DETACHED FROM THE PLATE, ALLOWING THE SCREWS TO BACK OUT. THE LEVEL OF THE AREA WITH THE DETACHED LOCKING MECHANISM NEVER FUSED AND A REVISION SURGERY WAS NECESSARY. THERE WAS NECK PAIN AND ARM PAIN PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED STATES THAT IMPLANT DATE(S): (B)(6) 2020 PATIENT DEMOGRAPHICS: GENDER- FEMALE, INITIALS C.H, AGE ¿ 75, DOB - (B)(6) 1945, WEIGHT ¿ 164 LBS ON (B)(6) 2020: PATIENT CAME FOR FOLLOW UP VISIT FOR LEG PAIN THAT SHE HAD BEEN GOING ON SINCE ABOUT 2013. THE PAIN WAS LOCATED INTO BOTH THE LEGS INTO THE POSTERIOR THIGHS TO THE LEVEL OF THE KNEES. SHE DEVELOPED SOME BLADDER ISSUE AND HAD DIFFICULTY MAKING IT TO THE BATHROOM. MRI DEMONSTRATE WORSENING STENOSIS L3-L5 NOW SEVER. SHE HAS A SCOLIOTIC CURVE FROM L1 DOWN TO S1. SHE HAS A GRADE 1 SLIP AT L3-4 AND L4-5. SURGEON DISCUSSED THAT ONE COULD CONSIDER A LONG SEGMENT SU

  Patient problems: Pain

  MAUDE report 12517325 ↗
• InjurySep 22, 2021Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (PATIENT, MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WITH STENOSIS DEGENERATIVE DISC DISEASE FOR ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SPINAL THERAPY AT C3-C6. IT WAS REPORTED THAT THE ZEVO LOCKING MECHANISM DETACHED FROM THE PLATE, ALLOWING THE SCREWS TO BACK OUT. THE LEVEL OF THE AREA WITH THE DETACHED LOCKING MECHANISM NEVER FUSED AND A REVISION SURGERY WAS NECESSARY. THERE WAS NECK PAIN AND ARM PAIN PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. (B)(6) 2022, EMAIL: ADDITIONAL INFORMATION RECEIVED STATES THAT IMPLANT DATE(S): (B)(6) 2020 PATIENT DEMOGRAPHICS: GENDER- FEMALE, INITIALS (B)(6), AGE ¿ 75, DOB - (B)(6) 1945, WEIGHT ¿ 164 LBS IT WAS REPORTED THAT: ON (B)(6) 2020: PATIENT CAME FOR FOLLOW UP VISIT FOR LEG PAIN THAT SHE HAD BEEN GOING ON SINCE ABOUT 2013. THE PAIN WAS LOCATED INTO BOTH THE LEGS INTO THE POSTERIOR THIGHS TO THE LEVEL OF THE KNEES. SHE DEVELOPED SOME BLADDER ISSUE AND HAD DIFFICULTY MAKING IT TO THE BATHROOM. MRI DEMONSTRATE WORSENING STENOSIS L3-L5 NOW SEVER. SHE HAS A SCOLIOTIC CURVE FROM L1 DOWN TO S1. SHE HAS A GRADE 1 SLIP AT L3-4 AND L4-5. SURGEON DISCUS

  Patient problems: Pain

  MAUDE report 12517305 ↗
• InjurySep 22, 2021Mechanics Altered; Mechanics Altered

  ¿ HISTORY OF ABDOMINAL SURGERY ¿ HISTORY OF ABDOMINOPLASTY ¿ HISTORY OF BACK SURGERY ¿ HISTORY OF KNEE REPLACEMENT ¿ HISTORY OF KNEE RIGHT SURGERY ON 27 JUNE 2019: FINDING: TECHNICALLY LIMITED EXAM WITH ONLY TRANSABDOMINAL IMAGING PERFORMED AND NEARLY EMPTY BLADDER AT START OF EXAM, STILL NOT AD EQUATELY DISTENDED EVEN FOLLOWING DRINKING 4 GLASS OF WATER AND RESCANNING 15 MINUTES LATER. IMPRESSION: LIMITED/ SUBOPTIMAL EXAM DUE TO LACK OF ENDOVAGINAL IMAGING AND INADEQUATE FILLING OF URINARY BLADDER. 1. NORMAL -SIZED UTERUS WITH ENDOMETRIAL STRIPE UNABLE TO BE MEASURED. 2. NONIDENTIFIED OVARIES. 3. NO FREE FLUID. ON 23 JULY 2019: FINDING: CAD REVIEWED. NO MASSES, SUSPICIOUS CALCIFICATION OR OTHER SIGNS OF MALIGNANCY ARE IDENTIFIED. THERE HAS BEEN NO SIGNIFICANT CHANGE IN THE APPEARANCE OF EITHER BREAST. IMPRESSION: NEGATIVE MAMMOGRAM. ON 02 AUG 2019: PATIENT HAD CT SCAN. FINDING: SPINE: REVERSAL NORMAL CERVICAL LORDOSIS CENTERED AT THE C4-5 LEVEL. TRACE RETROLISTHESIS C4 ON C5. ADVANCE DISC HEIGHT LOSS C4-5 THROUGH C6-7, MILD BONY FORAMINALNARROWING C4-5 THROUGH C5-6. NO EVIDENCE OF ACUTE BONY INJURY INVOLVING THE CERVICAL SPINE. SOFT TISSUE: ATHEROSCLEROTIC CALCIFICATION OF THE CAR

  Patient problems: Pain

  MAUDE report 12517264 ↗
• InjurySep 22, 2021Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (PATIENT, MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WITH STENOSIS DEGENERATIVE DISC DISEASE FOR ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SPINAL THERAPY AT C3-C6. IT WAS REPORTED THAT THE ZEVO LOCKING MECHANISM DETACHED FROM THE PLATE, ALLOWING THE SCREWS TO BACK OUT. THE LEVEL OF THE AREA WITH THE DETACHED LOCKING MECHANISM NEVER FUSED AND A REVISION SURGERY WAS NECESSARY. THERE WAS NECK PAIN AND ARM PAIN PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED STATES THAT IMPLANT DATE(S): (B)(6) 2020 PATIENT DEMOGRAPHICS: GENDER- FEMALE, INITIALS (B)(6), AGE ¿ 75, DOB - (B)(6)1945, WEIGHT ¿ 164 LBS ON (B)(6) 2020: PATIENT CAME FOR FOLLOW UP VISIT FOR LEG PAIN THAT SHE HAD BEEN GOING ON SINCE ABOUT 2013. THE PAIN WAS LOCATED INTO BOTH THE LEGS INTO THE POSTERIOR THIGHS TO THE LEVEL OF THE KNEES. SHE DEVELOPED SOME BLADDER ISSUE AND HAD DIFFICULTY MAKING IT TO THE BATHROOM. MRI DEMONSTRATE WORSENING STENOSIS L3-L5 NOW SEVER. SHE HAS A SCOLIOTIC CURVE FROM L1 DOWN TO S1. SHE HAS A GRADE 1 SLIP AT L3-4 AND L4-5. SURGEON DISCUSSED THAT ONE COULD CONSIDER A LONG SEGMENT

  Patient problems: Pain

  MAUDE report 12517209 ↗
• InjurySep 22, 2021Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (PATIENT, MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WITH STENOSIS DEGENERATIVE DISC DISEASE FOR ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SPINAL THERAPY AT C3-C6. IT WAS REPORTED THAT THE ZEVO LOCKING MECHANISM DETACHED FROM THE PLATE, ALLOWING THE SCREWS TO BACK OUT. THE LEVEL OF THE AREA WITH THE DETACHED LOCKING MECHANISM NEVER FUSED AND A REVISION SURGERY WAS NECESSARY. THERE WAS NECK PAIN AND ARM PAIN PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. (B)(6), PATIENT CAME FOR FOLLOW UP VISIT FOR LEG PAIN THAT SHE HAD BEEN GOING ON SINCE ABOUT 2013. THE PAIN WAS LOCATED INTO BOTH THE LEGS INTO THE POSTERIOR THIGHS TO THE LEVEL OF THE KNEES. SHE DEVELOPED SOME BLADDER ISSUE AND HAD DIFFICULTY MAKING IT TO THE BATHROOM. MRI DEMONSTRATE WORSENING STENOSIS L3-L5 NOW SEVER. SHE HAS A SCOLIOTIC CURVE FROM L1 DOWN TO S1. SHE HAS A GRADE 1 SLIP AT L3-4 AND L4-5. SURGEON DISCUSSED THAT ONE COULD CONSIDER A LONG SEGMENT SURGERY L1-S1 BUT WOULD FAVOR A MORE FOCAL APPROACH WITH A L3-5 LAMINECTOMY, LEFT SIDED L34, L45 TLIF AND L3-L5 POSTERIOR FUSION. AFTER CAREFUL CONSIDERATION, PATIENT ELECTED TO PRO

  Patient problems: Pain

  MAUDE report 12511654 ↗
• MalfunctionOct 16, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CERVICAL SURGERY FROM ANTERIOR APPROACH TO TREAT CERVICAL HERNIA. INTRA-OP, THE SCREW BROKE DURING SCREWING, BUT THE SURGEON SUCCEEDED IN REMOVING IT FROM THE VERTEBRA OF PATIENT. THE BROKEN SCREW WAS THEN REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. ALTHOUGH THE PROCEDURE WAS DELAYED BY 10 MINUTES, NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9198602 ↗
• InjuryMay 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TYPE OF PROCEDURE OR TECHNIQUE USED: ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) LEVELS IMPLANTED: C4-6 IT WAS REPORTED THAT POST-OP, THE IMPLANTED SCREW BROKE WHICH RESULTED IN NON UNION. FRAGMENTS INCLUDING DISTAL END OF SCREW THAT BROKE OFF REMAINED INSIDE THE PATIENT. PATIENT SUFFERED NECK/ARM PAIN AND THE PATIENT UNDERWENT REVISION SURGERY FOR THE REMOVAL OF IMPLANT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 8568204 ↗

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