Clydesdale™ Spinal System 2968255Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994485793), received between Feb 22, 2018 and Mar 21, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT WHICH IS USED IN OBLIQUE LATERAL INTERBODY FUSION (OLIF) SPINAL THERAPY FOR LUMBAR DISC HERNIATION. IT WAS REPORTED THAT THE CAGE WAS BROKEN. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16581120 ↗
• MalfunctionSep 2, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF SPINAL STENOSIS, L UMBAR DEGENERATION INVOLVED IN THE SPINAL FUSION THERAPY. IT WAS REPORTED THAT INTRA-OPERATIVELY, PRODUCT BROKE AND NO FRAGMENTS LEFT IN THE PATIENT'S BODY. PRODUCT WAS UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. THERE WAS DELAY IN OVERALL PROCEDURE TIME FOR 20 MINUTES. EVENT WAS ASSOCIATED WITH PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12412404 ↗
• MalfunctionJul 6, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT DIRECT LATERAL INTERBODY FUSION (DLIF) SURGERY AT L3/4 DISC SPACE DUE TO SPINAL STENOSIS. INTRA-OP, THE CAGE WAS BROKEN DURING IMPACTION. A FRAGMENT OF ABOUT 3MM PROXIMAL TO THE IMPLANT HOLDER BROKE AWAY FROM THE BODY OF THE CAGE. THE FRAGMENT WAS RETAINED IN THE HOLDER AND DISCARDED. THERE WERE NO PATIENT COMPLICATION OCCUR AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10231442 ↗
• MalfunctionSep 2, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR SLANT LATERAL FUSION. INTRA-OP, AFTER CAGE IMPLANTATION, IT WAS FOUND THAT THE POSITION OF THE CAGE WAS POOR; HENCE, IT WAS DECIDED TO TAKE THE CAGE OUT. WHEN EXPLANTING THE CAGE, ITS TAIL PART (HOLDING PART) BROKE. THE DOCTOR DECIDED TO USE THE OTHER AIDS TO SEE THE ORIGINAL CAGE INTO THE INTERVERTEBRAL SPACE. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8953945 ↗
• MalfunctionAug 19, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LUMBAR STENOSIS, LUMBAR AND CERVICAL DISC HERNIATION. HE UNDERWENT LUMBAR OBLIQUE SIDE INTERVERTEBRAL DISC RESECTION AT L3-L4 AND L4-L5, INTERVERTEBRAL CAGE BONE GRAFT FUSION AND NEUROLYSIS. INTRA-OP, THE CAGE BROKE. MOST OF THE BROKEN CAGE REMAINED IMPLANTED IN THE PATIENT. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8908087 ↗
• MalfunctionFeb 22, 2018Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION (OLIF) PROCEDURE DUE TO LUMBAR DEGENERATION. INTRA-OP, THE DOCTOR FOUND THAT THE IMPLANTED CAGE WAS FRACTURED. THE CAGE WAS REPLACED WITH A NEW ONE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NO FRAGMENTS OF THE BROKEN PRODUCT REMAINED INSIDE THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7288244 ↗

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-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-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
• 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