Clydesdale™ Spinal System 2968045Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994485861), received between Feb 13, 2017 and Feb 5, 2021 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (2 reports).

8 other recalls cover devices cleared under the same FDA submission (K100175, P000058); 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.

• InjuryFeb 5, 2021Crack; Migration; Crack; Migration

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN OBLIQUE APPROACH INTERBODY FUSION PROCEDURE IN A PATIENT DIAGNOSED WITH LUMBAR DISC HERNIATION. IT WAS REPORTED THAT THE FUSION CAGE WAS CRACKED, WHICH CAUSED THE PROTRUDING AND DISPLACEMENT OF THE FUSION CAGE AFTER THE SURGERY, AND REVISION SURGERY WAS PERFORMED. PRODUCT WILL BE RETURNED. NO PATIENT OTHER PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11284002 ↗
• InjuryOct 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTALS REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES REPORTABLE EVENT.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 10733628 ↗
• InjuryJan 2, 2019Migration; Migration

  PRE-OPERATIVE DIAGNOSIS: ADULT SPINAL DEFORMITY PROCEDURE: OBLIQUE LUMBAR INTERBODY FUSION (OLIF) IT WAS REPORTED THAT POST-OP, TRANSFERENCE TO THE LATERAL SIDE OCCURRED TO THE CAGE, THE NEXT DAY. THE LATERAL TRANSFERENCE WAS ABOUT 5 MM NOW. THE PHYSICIAN OBSERVED THAT THE EVENT OCCURRED DUE TO INTERVERTEBRAL DISC SPACE WAS NOT CLEANED UP WELL AND CAGE OF A WRONG SIZE WAS SELECTED. AT THAT TIME, IT WAS DECIDED TO PERFORM POSTERIOR FIXATION TWO WEEKS LATER. ON (B)(6) 2018, IT WAS PLANNED TO HAMMER THE CAGE IN ADDITIONALLY AND TO PERFORM POSTERIOR FIXATION ON (B)(6) 2018. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. PATIENT HAD PAIN IN THE LOWER LIMB.

  Patient problems: Pain

  MAUDE report 8210767 ↗
• MalfunctionJun 18, 2018Break; Break

  THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR SPONDYLOLISTHESIS AND UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION(OLIF) SURGERY. IT WAS REPORTED THAT DURING SURGERY, THE CAGE BROKE DURING IMPLANTATION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT.NO FRAGMENT OF THE BROKEN CAGE WERE REMAINING IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7608923 ↗
• InjuryFeb 13, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT WITH LUMBAR CANAL STENOSIS UNDERWENT ANTERIOR AND POSTERIOR INTERBODY FUSION SURGERY, IN WHICH, CAGE, SCREWS AND RODS WERE IMPLANTED AT L4-5. POST-OP, THE PATIENT UNDERWENT REVISION SURGERY DUE TO MIGRATION OF THE CAGE INSIDE THE PATIENT. IN THIS SURGERY, THE CAGE, SCREWS AND RODS WERE EXPLANTED. THE MIGRATED CAGE WAS REPLACED WITH A NEW CAGE IN THIS SURGERY. IT WAS ALSO REPORTED THAT THERE WAS A POSSIBILITY OF INFECTION IN THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Code Available

  MAUDE report 6325063 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100175, P000058. One submission often covers many models, so check the product and lot details in each record.

• Z-0440-2019 · Sep 27, 2018 · Terminated
  INFUSE Bone Graft X SMALL KIT REF 7510100
• Z-1595-2013 · May 28, 2013 · Terminated
  INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
• Z-1592-2013 · May 28, 2013 · Terminated
  INFUSE(R) Bone Graft,LARGE II KIT, REF 7510800, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
• Z-1590-2013 · May 28, 2013 · Terminated
  INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
• Z-1593-2013 · May 28, 2013 · Terminated
  INFUSE(R) Bone Graft, SMALL KIT, REF 7510200AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
• Z-1594-2013 · May 28, 2013 · Terminated
  INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
• Z-1589-2013 · May 28, 2013 · Terminated
  INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
• Z-1591-2013 · May 28, 2013 · Terminated
  INFUSE(R) Bone Graft, LARGE KIT, REF 7510600, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic