Clydesdale™ Spinal System 2942001Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00613994866523), received between Dec 9, 2024 and Aug 5, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Break” (22 reports).

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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2026Break; Product Quality Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50139607 ↗
• MalfunctionMay 12, 2026Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR DIRECT LATERAL INTERBODY FUSION SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER WAS DISASSEMBLED AND UNUSABLE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25146109 ↗
• MalfunctionMar 31, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR DIRECT LATERAL INTERBODY FUSION (DLIF). IT WAS REPORTED THAT THE INSERTER WAS BROKEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24740650 ↗
• MalfunctionMar 30, 2026Break

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR DIRECT LATERAL INTERBODY FUSION (DLIF). IT WAS REPORTED THAT THE INSERTER WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24729743 ↗
• MalfunctionMar 13, 2026Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE SHAFT OF THE INSERTER WAS BROKEN AND THE OTHER DEVICES WERE ALSO BROKEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24592737 ↗
• MalfunctionMar 13, 2026Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE SHAFT OF THE INSERTER WAS BROKEN AND THE OTHER DEVICES WERE ALSO BROKEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24587838 ↗
• MalfunctionMar 11, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT INSERTER BROKEN. NO PATIENT WAS INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24574110 ↗
• MalfunctionMar 10, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT, THE INSTRUMENT WAS BROKEN. IT WAS USED FOR DIRECT LATERAL INTERBODY FUSION. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557966 ↗
• MalfunctionMar 10, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED PRIOR TO USE. IT WAS REPORTED THAT THE INNER SHAFT THREADS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557824 ↗
• MalfunctionFeb 6, 2026Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE SHAFT OF THE INSERTER WAS BROKEN AND THE OTHER DEVICES WERE ALSO BROKEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277443 ↗
• MalfunctionJan 21, 2026Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR DIRECT LATERAL INTERBODY FUSION. IT WAS REPORTED THAT THE THREAD WIRE IS BROKEN AND UNUSABLE. IT WAS AN UNDESIRED DAMAGE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. IT WAS AN UNDESIRED DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24128042 ↗
• MalfunctionDec 8, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED PRIOR TO USE. IT WAS REPORTED THAT THE INSERTER BROKE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23741335 ↗
• MalfunctionDec 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR DIRECT LATERAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT THE INSERTER WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23701544 ↗
• MalfunctionNov 27, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR DIRECT LATERAL INTERBODY FUSION SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER BROKE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23663478 ↗
• MalfunctionNov 24, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN INSERTER USED FOR DIRECT LATE RAL INTERBODY FUSION. IT WAS REPORTED THAT INSERTER'S INNER SHAFT WAS BROKEN. THERE WERE NO PATIENT INVOLVED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629605 ↗
• MalfunctionNov 10, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT H AVING OBLIQUE LUMBAR INTERBODY FUSION FOR ARTRODESE LOMBAR. IT WAS REPORTED THAT THE TIP OF THE CAGE KEY BROKE DURING SURGERY, THE KEY WAS REPLACED WITH ANOTHER DURING THE PROCEDURE WITHOUT ANY HARM TO THE PATIENT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23508328 ↗
• MalfunctionOct 23, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LUMBAR ARTHRODE SIS PROCEDURE, THE KEY BROKE DURING SURGERY. IT WAS BEING HANDLED BY THE SURGEON. THE COMPANY'S INSTRUMENT TECHNICIAN WAS PRESENT DURING THE INCIDENT AND CLAIMS THAT IT WAS NOT MISUSED BY THE SURGEON. .THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368298 ↗
• MalfunctionOct 22, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR DILF. IT WAS REPORTED THAT THE TIP OF THE INSERTER WAS BROKEN DURING USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23355449 ↗
• MalfunctionOct 22, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT HAVING OBLIQUE LATERAL INTERBODY FUSION OLIF 2.5 ON TWO LEVELS AND OLIF 5.1 ON ONE LEVEL PROCEDURE, PLUS A REAR FIXING WITH THE LONGITUDE SYSTEM SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENT BREAK. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE MALFUNCTION REPORTED FOR THE PRODUCT INVOLVES THE BREAKAGE OF THE KEY, SPECIFICALLY AT THE TIP THAT HOLDS THE CAGE. THIS BREAKAGE WAS PROMPTLY IDENTIFIED DURING THE PROCEDURE WHEN THE DOCTOR NOTICED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23355417 ↗
• MalfunctionOct 22, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR DIRECT LATERAL INTERBODY FUSION SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER BROKE. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE INSTRUMENT BROKE IN THE RE-USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23355314 ↗
• MalfunctionJun 12, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE IN A PATIENT DIAGNOSED WITH LUMBAR ARTHRODESIS. IT WAS REPORTED THAT DL INSERTER BROKE WHEN USED TO CORRECTLY POSITION THE IMPLANT. 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 22193743 ↗
• MalfunctionMar 7, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL FUSION THERAPY. IT WAS REPORTED THAT THE DEVICE HAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED DEVICE WAS ALREADY USED BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21546381 ↗
• MalfunctionFeb 25, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR DIRECT LATERAL INTERBODY FUSION (DLIF) . IT WAS REPORTED THAT THE INSERTER IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21456237 ↗
• MalfunctionDec 9, 2024Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER <(>&<)> DISTRIBUTOR) REGARDING AN EVENT. IT WAS REPORTED THAT THE INSTRUMENT BROKE. THE TIP OF THE WRENCH THAT COMES INTO CONTACT WITH THE SCREW WAS DAMAGED. IT WAS NOT NECESSARY TO EXERT A GREAT FORCE ON THE WRENCH TO TURN IT FOR IT TO BE DAMAGED AND BECOME CROOKED, WITHOUT ITS ORIGINAL SHAPE. IT WAS IDENTIFIED THAT THE EQUIPMENT WAS DAMAGED BEFORE IT CAME INTO CONTACT WITH THE PATIENT (BY THE INSTRUMENTATION TECHNICIAN), SO ANOTHER INSTRUMENT WAS USED TO PERFORM THE SURGERY WITHOUT CAUSING INCONVENIENCE TO THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20876516 ↗