Clydesdale™ Spinal System 2968250Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00613994485809), received between Feb 28, 2018 and Jan 19, 2023 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2023Crack; Crack

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL(HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A SPINAL DEVICE USED IN POSTERIOR THORACOLUMBAR FUSION. IT WAS REPORTED THAT THE PRODUCT CRACKED WHEN IMPLANTED SO THE PRODUCT WAS TAKEN OUT. THE FUSION DEVICE WAS NOT EASY TO TAKE OUT, IT COULD ONLY BE PINCHED OUT A LITTLE BIT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. HENCE, NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16202436 ↗
• MalfunctionSep 5, 2022Break; Break

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED WITH REPORTED CAGE DURING OLIF PROCEDURE. THE PRE-OP DIAGNOSIS WAS SPINAL SPONDYLOLISTHESIS. IT WAS REPORTED THAT, THE CAGE WAS BROKEN. THE MAJOR PORTION OF BROKEN CAGE REMAINS IMPLANTED IN PATIENT BODY AND THERE WAS NO PLAN OR REVISION SCHEDULE TO EXPLANT THE CAGE. IT WAS MENTIONED, THE BROKEN CAGE FRAGMENT WOULD NOT BE SHIPPED FOR EVALUATION. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED, AND NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15355093 ↗
• MalfunctionSep 2, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A CAGE USED IN OLIF THERAPY FOR SP ONDYLOLISTHESIS. IT WAS REPORTED THAT WHEN THE PHYSICIAN WAS INTRODUCING THE IMPLANT INTO THE PATIENT WITH THE INSERTER, THE IMPLANT BROKE AT THE HOLDING POINT OF THE INSERTER. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15347397 ↗
• MalfunctionJun 28, 2022Break; Break

  INFORMATION WAS RECEIVED FROM REGULATORY BODY REGARDING A CAGE USED FOR OLIF. IT WAS REPORTED THAT ON (B)(6) 2022, AT ABOUT 14:45 IN THE 6TH OPERATING ROOM, WHEN THE DOCTOR WAS PERFORMING OLIF OPERATION ON THE LAST LUMBAR VERTEBRA(LUMBAR 2/3), MEDTRONIC MANUFACTURER FOUND THAT IT COULD NOT HOLD THE FUSION CAGE. AFTER CAREFUL INSPECTION AND COMPARISON, THE INSTRUMENT WAS MISSING THREE CLIPS, EACH OF WHICH WAS ABOUT 1*3MM IN SIZE. THE ITINERANT NURSES IMMEDIATELY BEGAN TO SEARCH, THE SURGEONS WASHED THEIR HANDS, THE NURSES, AND THE EQUIPMENT MANUFACTURERS IMMEDIATELY SEARCHED IN THE SURGICAL FIELD AND STERILE EQUIPMENT TABLE, BUT FAILED. SO THE VISITING NURSE REPORTED TO THE FOREMAN AND HEAD NURSE. THE THREE CLAMPING PIECES HOLDING FUSION DEVICE WERE SHAKEN OFF DUE TO HEAVY FORCE IN THE INITIAL USE PROCESS. FINALLY, ONE CLIP WAS FOUND IN THE BOTTLE CAP OF THE ASPIRATOR, AND THE OTHER TWO PIECES WERE NOT FOUND. THE CHIEF SURGEON ALSO WASHED THE INCISION SEVERAL TIMES. REPEATED C-ARM PHOTOGRAPHY DURING THE OPERATION COULD NOT FIND IT. FINALLY, SURGEON ASKED THE RADIOLOGY DEPARTMENT TO TAKE A BEDSIDE FILM TO CONFIRM THAT IT WAS NOT IN THE PATIENT. THEN THE INCISION WAS CLOSED AND THE PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14840469 ↗
• MalfunctionMay 3, 2022Break; Break

  INFORMATION WAS RECEIVED FROM OTHER, HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR LUMBAR STENOSIS. PROCEDURE OR THERAPY PERFORMED WAS OLIF THERAPY. LEVELS IMPLANTED 3-5. IT WAS REPORTED THAT THE PROXIMAL END OF THE CAGE WAS BROKEN. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. CAGE WAS BROKEN DURING THE IMPLANTATION. NO ADDITIONAL SURGERY REQUIRED AT THE MOMENT. THE REMAINING CAGE IS INSIDE THE PATIENT. THE SMALL PIECE THAT WAS BROKEN IT'S OUTSIDE THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14267064 ↗
• MalfunctionApr 6, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OLIF SPINAL THE RAPY FOR LUMBAR STENOSIS AT L3-L4. IT WAS REPORTED THAT THE PROXIMAL END OF THE CAGE BREAK. 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 14019531 ↗
• InjuryApr 19, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF LUMBAR SPINAL STENOSIS INVOLVED IN OBLIQUE LUMBAR INTERBODY FUSION (OLIF) PROCEDURE. IT WAS REPORTED THAT AT INTRA-OP, CAGE WAS BROKEN. THERE WERE NO BROKEN FRAGMENTS LEFT IN THE PATIENT'S BODY. THERE WAS NO ADDITIONAL SURGERY OR TREATMENT PROVIDED AS THE RESULT OF THIS EVENT. THERE WAS DELAY IN OVERALL PROCEDURE TIME FOR ABOUT 1 HOUR. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS THE RESULT OF THIS EVENT. EVENT WAS ASSOCIATED WITH THE PATIENT. PRODUCT WAS UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683939 ↗
• InjuryJul 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS OF LUMBAR SPINAL CANAL STENOSIS. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. THERE WERE PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. DEVICE REMAINS IMPLANTED IN PATIENT. THE PATIENT WHO RECEIVED OLIF ON L4/5 AND POSTERIOR PPS FIXATION WITH SEXTANT LAST TIME WAS PERFORMED RE-OPERATION THIS TIME ON (B)(6) 2020 DUE TO STENOSIS BETWEEN L2/3 AND L3/4. THERE WAS POSTERIOR DECOMPRESSION, SO PLIF WAS SELECTED THIS TIME. DECOMPRESSION WAS PERFORMED ON L2/3 ONLY. PLIF WAS PERFORMED ON L3/4. BONE FUSION HAS BEEN ACHIEVED ON L4/5, SO FINALLY FIXATION WAS PERFORMED WITH ROD ON L3/4. PREVIOUS DISEASE IS HT LUMBAR SPINAL CANAL STENOSIS AND LUMBAR DEGENERATIVE SPONDYLOLISTHESIS.

  Patient problems: Stenosis

  MAUDE report 10349109 ↗
• MalfunctionAug 6, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LATERAL INTERBODY FUSION (OLIF) AND MINIMALLY INVASIVE SPINE SURGERY (MIS) AT L4-5 DUE TO DEGENERATIVE DISC. INTRA-OP, THE TIP OF THE CAGE BROKE WHEN THE SURGEON WAS POSITIONING THE CAGE ORTHOGONALLY. THE IMPLANT WILL BE REMAINING IN PATIENT BODY UNLESS THERE IS ANY COMPLICATIONS DURING HER NEXT FOLLOW UP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8863595 ↗
• MalfunctionFeb 28, 2018Break; Break

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: LUMBAR DISC HERNIATION TYPE OF PROCEDURE OR TECHNIQUE USED :OLIF IT WAS REPORTED THAT INTRA-OP, THE CAGE BROKE BEFORE THE IMPLANTATION. THE CAGE DID NOT ENTER THE PATIENTS BODY FULLY WHEN THE EVENT OCCURRED. NO FRAGMENT OF THE IMPLANT REMAINING IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7302674 ↗

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-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-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-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-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-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-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