Clydesdale™ Spinal System 2922055Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994972897), received between Jun 27, 2019 and Jun 12, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE IN A PATIENT. IT WAS REPORTED THAT WHEN THE HCP IMPACTED THE CAGE TO ACCOMMODATE IT A PART OF IT BROKE. 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 22192085 ↗
• MalfunctionFeb 18, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING MULTI-STAGE ARTHRODESIS SURGERY, LUMBAR ARTHRODESIS USING AN ANTERIOR APPROACH, LUMBAR ARTHRODESIS (A-LIF) L5-S1 AND MULTI-STAGE ANTEROLATERAL LUMBAR ARTHRODESIS(O-LIF) L3-L4 AND L4-L5. IT WAS REPORTED THAT DURING L4-L5 O-LIF, AN ATTEMPT WAS MADE TO IMPLANT A CAGE. DURING IMPLANTATION, THE CAGE FAILED AT THE JUNCTION BETWEEN THE IMPLANT HOLDER AND THE CAGE. DURING OLIF L3-L4 FOR ANOTHER CAGE, THE SAME INCIDENT OCCURRED. DEVICE WAS IMPLANTED AND EXPLANTED ON SAME DAY. OPERATIVE TIME EXTENDED BY 15 MINUTES. PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WERE NO PATIENT SYMPTOMS REPORTED AND THERE WAS NO REVISION SURGERY PLANNED/ OCCURRED AS A RESULT OF THE EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21400230 ↗
• MalfunctionJun 27, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH ADJACENT LEVEL STENOSIS SUPERIOR TO PREVIOUS FUSION; AND UNDERWENT DIRECT LATERAL INTERBODY FUSION AT L2-L3. INTRA-OP, THE CAGE CRUMBLED UPON IMPLANTATION. FRAGMENTS OF THE BROKEN CAGE WERE REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8741967 ↗

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-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-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-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-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-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