VERTE-STACK® Spinal System 6240841Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994305091), received between Sep 6, 2017 and Oct 18, 2017 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (2 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 ↗