NA SD388.621Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034707105), received between Jul 5, 2022 and Jul 5, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (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.

• MalfunctionJul 5, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, PLACING PEDICLE SCREW HAD THE HANDLE FOR THE SCREW HOLDER COME APART. SPECIALLY THE WOOD PORT AND METAL THAT ATTACHES TO THE STICK FOR THE DELIVERY OF THE SCREW. FRAGMENTS WERE GENERATED AND WERE REMOVED EASILY WITHOUT ANY ADDITIONAL INTERVENTION. THE SOCKET WRENCH DRIVER WAS USED TO FINISH PLACING THE SCREW. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: SPINE-US (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1) THIS REPORT IS FOR ONE (1) CAP COVER FOR 388.621 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14919044 ↗