VERTE-STACK Spinal SystemRecalls & reported problems across all models

We found 14 models of VERTE-STACK Spinal System by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Dec 28, 2016 and Sep 20, 2026 — classified as 7 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

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

Most reported VERTE-STACK Spinal System problems

VERTE-STACK Spinal System models

14 models, most reported first. Each model has its own page with its reports, recalls and device details.

• VERTE-STACK Spinal System 6246011

  Spinal vertebral body replacement device
  4 reports
• VERTE-STACK® Spinal System 6240841

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  3 reports
• VERTE-STACK® Spinal System 9192507

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  2 reports
• VERTE-STACK® Spinal System 9193009

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  2 reports
• VERTE-STACK® Spinal System 6241041

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  1 report
• VERTE-STACK® Spinal System 6278244

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  1 report
• VERTE-STACK® Spinal System 6276006

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  1 report
• VERTE-STACK® Spinal System 6278025

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  1 report
• VERTE-STACK Spinal System 6246011

  Spinal vertebral body replacement device
  1 report
• VERTE-STACK® Spinal System 2961222

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  1 report
• VERTE-STACK® Spinal System 6287641

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  1 report
• VERTE-STACK® Spinal System 9192510

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  1 report
• VERTE-STACK® Spinal System 9193007

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  1 report
• VERTE-STACK® Spinal System 9193014

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  1 report

Recent VERTE-STACK Spinal System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50834758 ↗
• MalfunctionMar 12, 2026Mechanical Problem; Product Quality Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING SERVICING. IT WAS REPORTED THAT NEW SET CAME WITH INSERTERS AND INNER SHAFT WHICH DON'T THREAD IN FULLY, IT WAS NOTICED THAT BUTTON OF THE DRIVER STICKS AND IT APPEARS TIP OF INNER SHAFT IS BENT SLIGHTLY AND IT WAS NOTICED THAT EXTENDER TAB WAS BENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24577454 ↗
• MalfunctionMar 10, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING INSERTERS. IT WAS REPORTED THAT THERE WAS RESISTANCE TO THREADING THE INSERTER SHAFT ON THE INSIDE FOR BOTH INSERTERS, REQUIRING A LOT OF PRESSURE TO ASSEMBLE THE INSTRUMENTS. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24556028 ↗
• MalfunctionDec 29, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR REGARDING INSERTERS USED FOR ACDF (ANTERIOR CERVICAL DISCECTOMY AND FUSION). IT WAS REPORTED THAT THE TAMPS DOWN ALLOW THE STYLET TO EASILY PASS THROUGH THEM. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23908168 ↗
• MalfunctionDec 29, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR REGARDING INSERTERS USED FOR ACDF (ANTERIOR CERVICAL DISCECTOMY AND FUSION). IT WAS REPORTED THAT THE TAMPS DOWN ALLOW THE STYLET TO EASILY PASS THROUGH THEM. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907960 ↗
• MalfunctionNov 18, 2025Break; Crack; Break; Crack

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF-TRANSFORAM INAL LUMBAR INTERBODY FUSION SPINAL THERAPY FOR LUMBAR DEGENERATION REQUIRING 2 LEVEL TLIF PROCEDURE. LEVELS IMPLANTED AT L4/5 AND L5/S1. IT WAS REPORTED THAT AS THE SURGEON WAS STARTING TO PLACE THE CAGE INSITU IN THE DISC SPACE HE STARTED TO IMPACT THE INSERTER AND SUDDENLY THE CAGE CRACKED/BREAKAGE. THE CAGE LOOKED TO HAVE BEEN ATTACHED PROPERLY TO THE INSERTER BY THE SCRUB NURSE AND ALSO WASN¿T BEING FORCED INTO THE DISC SPACE WITH UNDUE FORCE.  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 23581103 ↗
• InjuryJan 5, 2021Migration; Migration

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA FIELD REPRESENTATIVE REGARDING A PATIENT WHO UNDERGONE SPINAL THERAPY WITH A PRE-OP DIAGNOSIS OF L4-5 TLIF. IT WAS REPORTED THAT DURING TLIF PROCEDURE THROUGH QUANDRANT RETRACTORS THE CAGE FLIPPED BEHIND THE SPINAL CORD WHEN TRYING TO INSERT IT INTO THE DISC SPACE DUE TO THE INSERTER GETTING LOOSE. THERE WAS 2 HOURS SURGICAL DELAY DUE TO REPORTED PRODUCT MALFUNCTION. CAGE HAD TO BE RETRIEVED THROUGH MIDLINE APPROACH. LAMINECTOMY HAD TO BE PERFORMED IN ADDITION TO REACH THE CAGE. THERE WAS NO INSTRUMENT OR IMPLANT BREAK. PRODUCT UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11116778 ↗
• InjuryMay 5, 2020Patient-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  PATIENT IMPLANTED WITH BIOLOGIC INFUSE RHBMP-2 USED IN COMBINATION WITH MODULAR VERTE-STACK ANATOMIC PEEK COMPONENTS FOR C5 SINGLE-LEVEL CERVICAL VERTEBRAL BODY REPLACEMENT (CORPECTOMY) AND C4-5/C5-6 ANTERIOR CERVICAL DISCECTOMY AND FUSION. PATIENT WAS NOT INFORMED OF 2008 FDA PUBLIC NOTICE WARNING OF LIFE-THREATENING COMPLICATIONS REFERENCING USE OF RHBMP-2 IN THE CERVICAL SPINE, NOR WAS PATIENT INFORMED THAT USE OF THE VERTE-STACK COMPONENTS IN THE CERVICAL SPINE IS CONTRAINDICATED ON THE DEVICE LABELING CLEARED BY THE FDA [K070173]. HTTPS://WEB.ARCHIVE.ORG/WEB/20160801140944/HTTPS://WWW.FDA.GOV/CDRH/510K/K070173.PDF. STUDIES SHOW RHBMP-2 EXPRESSION ASSOCIATED WITH METASTATIC PROSTATE CANCER PATIENTS [HTTPS://WWW.NCBI.NLM.NIH.GOV/PUBMED/2130271]. IN (B)(6) 2020, PATIENT WAS DIAGNOSED WITH METASTATIC PROSTATIC CANCER EXTRACAPSULAR INVOLVEMENT THROUGH PSA VELOCITY, MRI, FUSION BIOPSY AND HISTOLOGY. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Cancer; Failure of Implant

  MAUDE report 10028419 ↗
• InjuryOct 18, 2017Device Expiration Issue; Migration or Expulsion of Device; Off-Label Use; Migration; Device Expiration Issue; Migration or Expulsion of Device; Off-Label Use; Migration

  IT WAS REPORTED VIA MEDWATCH FORM, THAT THE SURGEON PERFORMED A TWO LEVEL ANTERIOR CERVICAL DISCECTOMY AT C4-C5. REPORTEDLY, "POST-OP COMPLICATIONS WERE DYSPHAGIA, DYSPHONIA, CHOKING, DIFFICULTY SWALLOWING, LOSS OF FEELING IN THE HANDS, FINGERS, AND ARMS PATIENT WILL BE UNDERGOING REVISION SURGERY SHORTLY". ALLEGEDLY," EXPIRED AND MISLABELED PRODUCT WAS IMPLANTED".

  Patient problems: Ambulation or Postural Difficulties; Choking; Dysphagia/ Odynophagia

  MAUDE report 6957316 ↗
• InjuryOct 3, 2017Migration or Expulsion of Device; Off-Label Use; Device Dislodged or Dislocated

  I WAS IMPLANTED WITH TWO PEEK CORPECTOMY CAGES INTO THE CERVICAL SPINE (PROCODE MQP). POST-OP IMAGING STUDIES SHOW THAT ONE OF THE TWO CAGES DISLOCATED AND MIGRATED INTO THE SPINAL CANAL. DEVICE-LABELING STATES THAT USE IN THE CERVICAL SPINE IS AN ABSOLUTE CONTRAINDICATION, YET THE REVIEW OF THE DEVICE CONSTRUCT SHOWS THAT THE DEVICE IS DESIGNED TO FIT INTO THE CERVICAL SPINE. THE TWO PART NUMBERS INVOLVED ARE 6240841 AND 6240861. ALSO PART NUMBER 6240841 EXPIRED IN 2010, BUT WAS IMPLANTED IN 2011. I WILL REQUIRE REVISION SURGERY. THE IMPLANTING SURGEON DID NOT DISCLOSE THE CONTRAINDICATED USE AND DEVICE-RELATED RISK ASSOCIATED WITH DEVICE USE IN THE CERVICAL SPINE, NOR DID HE DISCLOSE HE IS BEING PAID BY THE DEVICE SPONSOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6910896 ↗
• InjurySep 6, 2017Shelf Life Exceeded

  ON (B)(6) 2011, DR. (B)(6) PERFORMED A TWO-LEVEL ANTERIOR CERVICAL DISCECTOMY AT C4-C5, C5-C6 WITH VERTE-STACK ANATOMIC END-CAPS, THE ENDCAP SIZE IS 14 X 11MM FOOTPRINT BY 8MM HEIGHT LORDOTIC. DEVICE LABELING STATES IT IS CONTRAINDICATED FOR THE CERVICAL SPINE, THE SURGEON DID NOT DISCLOSE THAT THE DEVICE WAS NOT APPROVED FOR USE IN THE NECK NOR DID THE SURGEON DISCLOSE THAT THE DEVICE HAS NOT BEEN SHOWN TO BE SAFE AND EFFECTIVE. I DEVELOPED POST-OP COMPLICATIONS INCLUDING BUT NOT LIMITED TO DYSPHAGIA, DYSPHONIA, CHOKING, DIFFICULTY SWALLOWING AND LOSS OF FEELING IN THE HANDS, FINGERS, AND ARMS I WILL BE UNDERGOING REVISION SURGERY SHORTLY. THE DEVICE LABELING DIRECTS THE DOCTOR TO IMPLANT THE DEVICE INTO THORACIC/LUMBAR SPINE, BUT THE SIZE AND SHAPE OF THE DEVICE ONLY FITS INTO THE CERVICAL SPINE. THE EXP DATE IS MAR 2010. DR. (B)(6) NEVER DISCLOSED THAT HE WAS GOING TO USE AN EXPIRED AND MISLABELED PRODUCT AT THE (B)(6) MEDICAL CENTER.

  Patient problems: Choking; Dysphasia; No Code Available; Numbness

  MAUDE report 6845585 ↗
• MalfunctionSep 5, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT PRESENTED WITH PRE-OP DIAGNOSIS AS LUMBAR DEGENERATION. FOR WHICH, PATIENT UNDERWENT POSTERIOR LUMBER INTERBODY FUSION (PLIF) AT LEVELS L2-5. INTRA-OP, DURING THE IMPLANTATION OF CAGE, THE SURGEON HAD TO IMPACT THE CAGE TO GET IT INTO THE DISC SPACE, DURING WHICH THE CAGE BROKE. ANOTHER CAGE WAS USED FOR INSERTION WHICH TOO BROKE DURING IMPACTION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE IMPLANT REMAINED IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6841133 ↗
• MalfunctionSep 5, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT PRESENTED WITH PRE-OP DIAGNOSIS AS LUMBAR DEGENERATION. FOR WHICH, PATIENT UNDERWENT POSTERIOR LUMBER INTERBODY FUSION (PLIF) AT LEVELS L2-5. INTRA-OP, DURING THE IMPLANTATION OF CAGE, THE SURGEON HAD TO IMPACT THE CAGE TO GET IT INTO THE DISC SPACE, DURING WHICH THE CAGE BROKE. ANOTHER CAGE WAS USED FOR INSERTION WHICH TOO BROKE DURING IMPACTION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE IMPLANT REMAINED IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6841129 ↗
• MalfunctionAug 24, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION ON C4-5 DUE TO CERVICAL DISC PROTRUSION. INTRA-OP, DURING INSERTION OF THE IMPLANT IN THE PATIENT'S BODY WHEN SURGEON WAS TAPING THE IMPLANT WITH MALLET, THE IMPLANT BROKE. THE IMPLANT WAS EXPLANTED ON THE PROCEDURE DATE ITSELF. NO FRAGMENTS OF THE IMPLANT ARE REMAINED IN THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6816023 ↗
• InjuryJul 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2011, PATIENT UNDERWENT CERVICAL CORPECTOMY USING PEEK CAGE AND RHBMP-2. POST-OPERATIVELY, ON (B)(6) 2011, THE PATIENT DEVELOPED COMPLICATIONS LIKE CHOKING AND WEAKNESS. REPORTEDLY, PATIENT IS SUFFERING FROM CANCER AND IS UNABLE TO PICK UP MORE THAN A GALLON OF MILK AND IS UNABLE TO WORK.

  Patient problems: Ambulation or Postural Difficulties; Choking; Weakness

  MAUDE report 6685546 ↗

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