Clydesdale™ Spinal System 2968245Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994485816), received between Aug 23, 2019 and Jan 2, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL(HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A SPINAL DEVICE USED IN OBLIQUE LATERAL INTERBODY FUSION(OLIF) L4 -S1. IT WAS REPORTED THAT THE CAGE WAS IMPLANTED IN THE PATIENT, ONLY THE SMALL DISTAL END OF THE CAGE BROKE OFF. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS L4 - S1 STENOSIS. THERE WERE NO PATIENT SYMPTOMS IN THIS EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE PRODUCT WILL NOT BE EXPLANTED, THE INFORMATION HAS BEEN CONFIRMED WITH THE PHYSICIAN. NO FRAGMENT WAS REPORTED TO BE LEFT IN THE PATIENT. DISTAL FRAGMENT THAT BROKE OFF, REMAINED ON THE DISTAL END OF THE DLIF TLIF INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16082197 ↗
• MalfunctionNov 30, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT SPINAL THERAPY FOR OSTEOPOROSIS, SCOLIOSIS, LUMBAGO DISEASE. IT WAS REPORTED THAT THE CAGE WAS BROKEN, AND NO FRAGMENTS WERE LEFT INSIDE THE PATIENT. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED. DELAYED THE ENTIRE OPERATION TIME. DETAILS: THE HOLDING POSITION WAS BROKEN WHEN THE FUSION WAS INSERTED HALFWAY, AND IT COULD NOT BE PUSHED IN, AND THE HOLDER COULD NOT CONTINUE TO HOLD THE PROSTHESIS. FINALLY, THE PROSTHESIS COULD ONLY BE TAKEN OUT WITH LONG PLIERS. IT WAS ORIGINALLY PLANNED TO USE A 12*45 FUSION, BUT WAS FORCED TO USE A 12*50 FUSION. THE DELAY IN THE SURGERY WAS LESS THAN 60 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10917577 ↗
• MalfunctionJul 6, 2020Mechanical Problem; Mechanical Problem

  PRE-OPERATIVE DIAGNOSIS: SPONDYLOLISTHESIS PROCEDURE PERFORMED: OBLIQUE LUMBAR INTERBODY FUSION (OLIF) INTRA-OP, THE FUSION DEVICE HAD SCREW THREAD ISSUE. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10231976 ↗
• InjuryAug 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LATERAL INTERBODY FUSION (OLIF) OF 3 INTERVERTEBRAL DISCS AT L2-3,L3-4,L4-5 DUE TO UNKNOWN REASON. POST-OP, THE PATIENT COMPLAINTS ABOUT PAIN BECAUSE OF THE CAGE INSERTED BETWEEN L4 AND L5 INTERVERTEBRAL DISC SPACE. ALSO, NFECTION OCCURRED TO THE INTERVERTEBRAL DISC SPACE BETWEEN L4 AND L5 AND THE PEDICLE ON THE RIGHT SIDE OF L5. PATIENT UNDERWENT REVISION SURGERY AS A RESULT OF THIS EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 8924880 ↗

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-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-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-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-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-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