Clydesdale™ Spinal System 2922450Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994972446), received between Nov 7, 2024 and Jan 30, 2025 — classified as 1 injury, 1 malfunction.

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

8 other recalls cover devices cleared under the same FDA submission (K113528, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2025Migration; Migration

  INFORMATION RECEIVED FROM CLINICAL STUDY, HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT. AN ASSESSMENT FOR PRODUCT/THERAPY/PROCEDURE RELATEDNESS WAS MADE BY THE INVESTIGATOR. THIS AE RELATED TO A STUDY PROCEDURE WAS POSSIBLE. THERE WAS PROCEDURE RELATIONSHIP. THE AE WAS NOT RELATED TO THE INFUSE. THE AE WAS NOT RELATED TO DEVICES/COMPONENTS OTHER THAN INFUSE. THE AE WAS NOT RELATED TO AN UNDERLYING CONDITION OR DISEASE. THE AMOUNT OF BLEEDING DURING THE PROCEDURE WAS A LITTLE HIGH, BUT WAS NOT RELATED TO INFUSE. AN ASSESSMENT FOR PRODUCT/THERAPY/PROCEDURE RELATEDNESS WAS MADE BY THE SPONSOR - DIFFERENT FROM INVESTIGATOR. THIS AE RELATED TO A STUDY PROCEDURE: CAUSAL RELATIONSHIP AE TERM: BLOOD LOSS OCCURRED DURING SURGERY BLOOD LOSS OCCURRED DURING SURGERY, SO BLOOD TRANSFUSION WAS PERFORMED. THERE ARE NO ADDITIONAL RECORDS IN THE EMR. THE AE RESULT IN TREATMENT. BLOOD TRANSFUSION WAS DONE AS A RESULT OF AE. THE PATIENT OUTCOME WAS RECOVERED. THE AE END: ON (B)(6) 2024, SERIOUSNESS CRITERION: MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY, OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION: YES, THE DATE THE SITE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21271724 ↗
• InjuryNov 7, 2024Migration; Migration

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT (B)(4). IT WAS REPORTED THAT, THERE WAS CAGE MIGRATION AND ANTEROLISTHESIS WAS OBSERVED. PATIENT HAD LEG PAIN, AND REVISION SURGERY WAS PERFORMED, CAGE WAS REPOSITIONED. A CAGE WAS INSERTED DURING THE OBLIQUE LUMBAR INTERBODY FUSION SURGERY, AND MIGRATION OF THE CAGE WAS OBSERVED IN THE POST-OPERATIVE MAGNETIC RESONANCE IMAGING. INVESTIGATOR ASSESSMENT STATES, THE ADVERSE EVENT WAS NOT RELATED TO PROCEDURE, INFUSE, OTHER DEVICES NOR UNDERLYING CONDITION OR DISEASE. SPONSOR ASSESSMENT STATES, CAUSALLY RELATED TO THE DEVICES/COMPONENTS OTHER THAN INFUSE, POSSIBLE RELATED TO PROCEDURE AND DEVICE. OUTCOME OF THE ADVERSE EVENT WAS RECOVERED/RESOLVED ON (B)(6)2024. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 20628723 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113528, 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-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-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-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-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-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
• 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