Clydesdale™ Spinal System 2926845Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994972514), received between Jan 11, 2017 and Jan 11, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 11, 2017Break; Break

  IT WAS REPORTED THAT PATIENT WITH DEGENERATIVE DISC DISEASE UNDERWENT OBLIQUE LATERAL INTERBODY FUSION AT L2/3, L3/4, L4/5.DURING IM PLANTATION, THE CAGE BROKE. ALL FRAGMENTS WERE REMOVED AFTER MUCH EFFORTS. SECOND ATTEMPT TO IMPLANT ANOTHER SIMILAR CAGE ALSO RESULTED IN CAGE BREAKAGE BUT WAS LEFT IN PLACE IN BROKEN CONDITION. DURING THE SECOND ATTEMPT, THE MAJORITY OF THE IMPLANT WAS LEFT IN THE PATIENT. THE SURGERY TOOK LONGER THAN EXPECTED. NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NO REVISION IS PLANNED CURRENTL Y.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6240239 ↗
• MalfunctionJan 11, 2017Break; Break

  IT WAS REPORTED THAT PATIENT WITH DEGENERATIVE DISC DISEASE UNDERWENT OBLIQUE LATERAL INTERBODY FUSION AT L2/3, L3/4, L4/5. DURING IM PLANTATION, THE CAGE BROKE. ALL FRAGMENTS WERE REMOVED AFTER MUCH EFFORTS. SECOND ATTEMPT TO IMPLANT ANOTHER SIMILAR CAGE ALSO RESULTED IN CAGE BREAKAGE BUT WAS LEFT IN PLACE IN BROKEN CONDITION. DURING THE SECOND ATTEMPT,THE MAJORITY OF THE IMPLANT WAS LEFT IN THE PATIENT. THE SURGERY TOOK LONGER THAN EXPECTED. NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NO REVISION IS PLANNED CURRENTLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6240238 ↗

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-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
• 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-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-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-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