NA 03.124.004Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982074980), received between May 4, 2020 and May 4, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, THE NUT FOR INTERLOCKING BOLTS FOR PERCUTANEOUS INSERTION HANDLE WAS DIFFICULT TO THREAD ONTO THE INTERLOCKING BOLT FOR PERCUTANEOUS INSERTION HANDLE. THE TECHNICIAN WAS UNABLE TO USE THE 2 DEVICES TO ATTACH THE UNKNOWN AIMING ARM TO THE UNKNOWN PLATE. THE SURGEON HAD TO ASSIST THE TECHNICIAN AT THE BACK OF THE TABLE TO COMPLETE THE ASSEMBLY. THE SURGEON HAD TO STOP WHAT HE WAS DOING TO ASSIST THE TECHNICIAN IN THE ASSEMBLY OF THE PARTS TO COMPLETE THE SURGERY SUCCESSFULLY. IT WAS TOO DIFFICULT TO THREAD AND HAVE THESE 2 DEVICES LOOKED AT. THERE WAS A SURGICAL DELAY OF 2 MINUTES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES REPORTED: UNKNOWN AIMING ARM (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES 2 DEVICES. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10021961 ↗