N/A 7480150Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00721902762994), received between May 25, 2021 and Jul 6, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN UNKNOWN INDICATION FOR POSTERIOR FUSION AND DECOMPRESSION WITH SOLERA INSTRUMENTATIONS. IT WAS REPORTED THAT WHEN USING THE COUNTER TORQUE THE SURGEON IMPACTED WITH A MALLET TO SEAT THE COUNTER TORQUE AND ROD TO THE SOLERA SCREW. UPON DOING THE CONNECTION BETWEEN THE COUNTER TORQUE AND HANDLE FRACTURED ON THE INSTRUMENT. ANOTHER SETS OPENED TO ACQUIRE THE SAME INSTRUMENT TO REPLACEMENT AND CARRIED ON WITH THE PROCEDURE. THERE WAS A MINOR DELAY IN PROCEDURE. PRODUCTS WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE COUNTER TORQUE PRODUCT CAME IN CONTACT WITH THE SOLERA SCREWS WHICH WERE IMPLANTED AND ATTACHED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12119536 ↗
• MalfunctionMay 26, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING UNKNOWN INDICATION FOR SPINAL THERAPY. IT WAS REPORTED THAT DRIVERS BROKE. THERE WERE NO PATIENT SYMPTOMS/ COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11883050 ↗
• MalfunctionMay 25, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING IDIOPATHIC SCOLIOSIS FOR SPINAL THERAPY. IT WAS REPORTED THAT DRIVERS BROKE. THERE WERE NO PATIENT SYMPTOMS/ COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11874874 ↗