Clydesdale™ Spinal System 2922255Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994972842), received between Feb 7, 2017 and Aug 22, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2017Break; Break

  IT WAS REPORTED THAT PATIENT WITH LUMBAR STENOSIS AND SPONDYLOLISTHESIS AT L4-5 UNDERWENT L4-5 OBLIQUE LUMBAR INTERBODY FUSION. INTRA-OP, SPACER CRACKED WHILE ATTEMPTING TO MAKE THE ORTHOGONAL MOVEMENT DURING THE IMPLANTATION PROCESS. THIS WAS EXPLANTED AND A SECOND SPACER WAS USED WHICH ALSO CRACKED WHILE ATTEMPTING TO MAKE THE ORTHOGONAL MOVEMENT. THE FIRST CAGE WAS EXPLANTED COMPLETELY AND TWO FRAGMENTS WERE GENERATED FROM SECOND SPACER WHICH WERE RECOVERED FULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6809416 ↗
• MalfunctionAug 22, 2017Break; Break

  IT WAS REPORTED THAT PATIENT WITH LUMBAR STENOSIS AND SPONDYLOLISTHESIS AT L4-5 UNDERWENT L4-5 OBLIQUE LUMBAR INTERBODY FUSION. INTRA-OP, SPACER CRACKED WHILE ATTEMPTING TO MAKE THE ORTHOGONAL MOVEMENT DURING THE IMPLANTATION PROCESS. THIS WAS EXPLANTED AND ANOTHER CAGE WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6809412 ↗
• MalfunctionFeb 7, 2017Break; Break

  PRE-OP DIAGNOSIS: DEGENERATIVE DISC DISEASE PROCEDURE: OBLIQUE LUMBAR INTERBODY FUSION LEVELS IMPLANTED: L2-S1 IT WAS REPORTED THAT DURING SURGERY, A CAGE BROKE UPON IMPLANTATION. THE FRAGMENTS WERE REMOVED AND BULK OF THE IMPLANT WAS LEFT IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6306295 ↗

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-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-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-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-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-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