N/A 5584150Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169043664), received between Sep 16, 2020 and Apr 30, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN R EINSERTION OPERATION SPINAL SURGERY FOR POST OPERATIVE INFECTION. IT WAS REPORTED THAT THE DEVICE WAS BROKEN DURING FINAL TIGHTENING. NO FURTHER COMPLICATIONS WERE REPORTED. 2023-NOV-16_ARED (REP): ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE IS NO ALLEGATION/MALFUNCTION ASSOCIATED WITH INITIAL IMPLANTED MDT PRODUCT AND INFECTION IS ALSO NOT RELATED TO MEDTRONIC IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19211788 ↗
• MalfunctionJan 18, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING L3/4 TLIF FOR STENOSIS. IT WAS REPORTED THAT THE BASE OF THE COUNTER HANDLE BROKE OFF AT THE 3RD FINAL TIGHTENING. NO INSTRUMENT DEBRIS LEFT IN THE PATIENT'S BODY. THERE WAS A DELAY OF LESS THAN 60 MINUTES DUE TO THIS EVENT. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16192204 ↗
• MalfunctionAug 19, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DI AGNOSIS FOR LUMBAR SPINAL STENOSIS. PROCEDURE OR THERAPY PERFORMED WAS POSTERIOR LUMBAR FUSION THERAPY. LEVELS IMPLANTED 1. IT WAS REPORTED THAT AFTER PLACING SET SCREWS, SURGEON WENT TO USE COUNTER TORQUE TO BREAK OFF SET SCREW TOPS AND THE COUNTER TORQUE HANDLE BROKE OFF THE SHAFT OF THE INSTRUMENT. THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15256938 ↗
• MalfunctionOct 4, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH INFECTION HAVING HARDWARE REMOVAL FOR SPINAL THERAPY. IT WAS REPORTED THAT SCREWDRIVERS AND COUNTER TOQUE BROKE DURING A HARDWARE REMOVAL PROCEDURE. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12567005 ↗
• MalfunctionJul 8, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN UNKNOWN INDICA TION FOR SPINAL THERAPY. IT WAS REPORTED THAT THE COUNTER TORQUE BROKE. THERE WERE NO FRAGMENTS OF THE IMPLANTS OR INSTRUMENTS REMAINED IN THE PATIENT'S BODY. PRODUCT WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT PRE-OP DIAGNOSIS IS UNKNOWN DUE TO PATIENT CONFIDENTIALITY. PROCEDURE INVOLVED WAS FUSION. PRODUCT DIDN'T COME IN CONTACT WITH THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE ITEM WAS IN CONTACT WITH A SCREW WHEN IT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12133591 ↗
• 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 12119588 ↗
• MalfunctionFeb 3, 2021Break; Use of Device Problem; Break; Use of Device Problem

  INFORMATION RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA ¿ OP FOR A PATIENT WITH UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT, THE INSTRUMENT WAS ACCIDENTALLY BROKEN DURING A CASE. IT WAS MENTIONED AS WHEN THE SURGEON¿S PA TRIED SPINNING THE COUNTER TORQUE INSTEAD OF THE BREAK OFF T-HANDLE, AND ACCIDENTALLY SNAPPED THE COUNTER TORQUE IN HALF. THE PRODUCT CAME IN CONTACT WITH THE PATIENT, BUT THERE WAS NO HARM OCCURRED. IT WAS MENTIONED THAT THERE WAS NO FRAGMENT OF THE BROKEN INSTRUMENT REMAINED IN PATIENT. THERE WAS NO ADDITIONAL TREATMENT OR SURGERY PERFORMED TO PATIENT AS A RESULT OF THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS TO PATIENT OR PHYSICIAN WERE REPORTED OR ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11273288 ↗
• MalfunctionSep 16, 2020Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE/ DISTRIBUTOR REGARDING A PATIENT HAVING SPINAL THERAPY DUE TO SPINE SPONDYLOSIS. IT WAS REPORTED THAT DURING FINAL FIXATION OF THE SET SCREWS DURING THE PROCEDURE, DRIVER BROKE. THERE WERE NO PATIENT COMPLICATIONS/ SYMPTOMS WERE REPORTED AND THE PROCEDURE WAS COMPLETED. THE PRODUCT WILL BE RETURNED. THERE WERE NO FURTHER COMPLICATIONS REPORTED. ON 2020-08-31, UPDATE RECEIVED THE PROCEDURE INVOLVED WAS SPINAL FIXATION SPONDYLISTHESIS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10540010 ↗