N/A 5484147Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994591937), received between Jun 29, 2018 and Oct 28, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2024Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY (UF) VIA MANUFACTURER REPRESENTATIVE REGARDING A PRODUCT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20542481 ↗
• MalfunctionAug 8, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCTS THAT IS USED IN REVISION SURGERY TO REMOVE THE HARDWARE FOR STENOSIS. IT WAS REPORTED THAT TIPS OF THE DEVICES WERE BROKEN WHEN ATTEMPTING TO MOVE OLD HARDWARE. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17478823 ↗
• MalfunctionJun 6, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING EXTENSION OF SCOLIOSIS GROWTH RODS/SCOLIOSIS WITH SOLERA 4.75 SYSTEM DUE TO SCOLIOSIS. IT WAS REPORTED THAT THE SETSCREWS WAS EXTREMELY HARD TO REMOVE, HENCE THE BREAKING OF THE DRIVERS. THERE WAS NO PATIENT SYMPTOM REPORTED. THE SURGERY WAS DELAYED TO GET EXTRA DRIVERS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14600755 ↗
• MalfunctionDec 7, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR NON UNION/FAILED FUSION AT L2-S1. IT WAS REPORTED THAT WHEN SURGEON WAS TRYING TO PUT THE SCREW IN, THE FORCE REQUIRED TO IMPLANT THE SCREW WAS TOO GREAT AND THE TIP OF THE DRIVER SNAPPED. THE DRIVER CAME IN CONTACT WITH THE IMPLANT WITH IN PATIENT. 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 12946238 ↗
• InjuryJul 31, 2020Material Fragmentation; Material Twisted/Bent; Material Fragmentation; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA FIELD REPRESENTATIVE REGARDING A PATIENT WHO UNDERGONE SPINAL THERAPY WITH AN INDICATION OF EOS. IT WAS REPORTED THAT DURING INTRA-OP, THE TIP OF THE DRIVER WAS TWISTED BROKEN AND REMAINED IN THE PATIENT'S BODY. IT OCCURRED DURING FINAL TIGHTENING AND THE FRAGMENT WAS DIFFICULT TO RETRIEVE BECAUSE IT WAS STUCK IN THE SET SCREW. ADDITIONAL INFORMATION RECEIVED THAT THE REPORTED INSTRUMENT WAS USED IN OPERATION, BUT IT WAS NEVER PUT IN THE PATIENT BODY. THERE WAS NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT. THE BROKEN PART WILL BE REMOVED IN 5 TO 10 YEARS, AND THE TIME IS UNKNOWN AT THIS TIME. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10348688 ↗
• MalfunctionJun 29, 2018Break; Break

  PRE-OP DIAGNOSIS: SCOLIOSIS IN THORACIC VERTEBRA PART LEVELS IMPLANTED: T2-L3 IT WAS REPORTED THAT ON (B)(6) 2018, DURING A OPERATION TO EXTEND THE INLINE CONNECTOR, TIP OF THE DRIVER BROKE WHILE INSERTING THE SET SCREW AGAIN DURING EXTENSION. NO FRAGMENTS OF THE DRIVER WERE REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7649985 ↗