Clydesdale™ Spinal System 2968050Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00613994485854), received between Mar 11, 2019 and Jun 9, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2026Break

  ON (B)(6) 2025 MPXR 1351860 (REP, HCP, FOR): INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OBLIQUE LUMBAR INTERBODY FUSION (OLIF) FOR LUMBAR SPINAL STENOSIS. IT WAS REPORTED THAT WHEN THE FUSION DEVICE WAS ALMOST IN POSITION DURING IMPLANTATION, THE TIP END CONNECTED TO THE FUSION DEVICE BROKE. THE BROKEN PART WAS REMOVED, BUT THE PORTION ALREADY IMPLANTED COULD NOT BE REMOVED. SINCE IT WAS RELATIVELY INTACT, IT WAS LEFT INSIDE THE PATIENT TO SERVE AS STRUCTURAL SUPPORT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25446288 ↗
• MalfunctionMar 2, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR LUMBAR FUSION. IT WAS REPORTED THAT SPLITTING OCCURRED DURING INTRAOPERATIVE IMPLANTATION, AND THEN THE PRODUCT WAS TAKEN OUT. 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 16468056 ↗
• MalfunctionApr 6, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH UNKNOWN INDICATION FOR OLIF. IT WAS REPORTED THAT THE PITUITARY AND TWO CAGES BROKE DURING INSERTION. THERE WERE NO FRAGMENTS OF THE IMPLANTS OR INSTRUMENTS REMAINED IN THE PATIENT'S BODY. THE CAGES EXPLANTED COMPLETELY AND WILL NOT BE RETURNED. THE PITUITARY WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PRODUCT CAME IN CONTACT WITH PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617472 ↗
• MalfunctionApr 6, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH UNKNOWN INDICATION FOR OLIF. IT WAS REPORTED THAT THE PITUITARY AND TWO CAGES BROKE DURING INSERTION. THERE WERE NO FRAGMENTS OF THE IMPLANTS OR INSTRUMENTS REMAINED IN THE PATIENT'S BODY. THE CAGES EXPLANTED COMPLETELY AND WILL NOT BE RETURNED. THE PITUITARY WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PRODUCT CAME IN CONTACT WITH PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617463 ↗
• MalfunctionMar 16, 2021Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH OBLIQUE LATERAL INTERBODY FUSION THERAPY. IT WAS REPORTED THAT THE IMPLANT WAS PULL OUT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11490664 ↗
• MalfunctionJul 11, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION AT L3-L5 DUE TO SPINAL STENOSIS AT L3-L5. INTRA-OP, DURING IMPLANTATION, THE PEEK PART OF THE CAGE (WHERE THE CAGE CONNECTS TO THE INSERTER) BROKE. THE BROKEN FRAGMENT OF THE IMPLANT WAS REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8780123 ↗
• MalfunctionMar 11, 2019Break; Break

  PRE-OPERATIVE DIAGNOSIS: DEGENERATIVE DISC DISEASE LEVEL IMPLANTED: L3-4 PROCEDURE: OBLIQUE LUMBAR INTERBODY FUSION (OLIF) IT WAS REPORTED THAT INTRA-OP, TAB OF THE CAGE, WHERE CAGE IS ATTACHED TO INSERTER BROKE DURING INSERTION. THE ENTIRE IMPLANT IS STILL INSIDE THE PATIENT. PATIENT COMPLICATIONS WERE REPORTED UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8408669 ↗

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-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
• 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-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-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-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