NA 219446Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705006526), received between Jan 6, 2022 and Jun 8, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED BY THE SALES REP IN ESTONIA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, THE SURGEON HAD BIG TROUBLES GETTING MODULAR DRIVER, 23MM DEVICE OUT OF THE SCREW AFTER IMPLANTATION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DISTAL TIP ON THE DEVICE WAS BENT. ACCORDING TO THE REPORT, THE SURGEON USED EXTRA FORCE TO GET THE DRIVER OUT AND COMPLETE PROCEDURE WITH A SURGICAL DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14632066 ↗
• MalfunctionJan 6, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT THE TIP OF THE MODULAR DRIVER, 23MM DEVICE GOT BENT DURING STERILIZATION. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13179030 ↗