NA 209.880Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982151216), received between May 21, 2020 and May 20, 2021 — classified as 2 injuries, 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 18, 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.

• InjuryMay 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A PATIENT UNDERWENT A HARDWARE REMOVAL PROCEDURE DUE TO PROMINENCE. CREATING PAIN AT THE OPERATIVE SITES. HARDWARE WAS INTACT. THERE WERE NO ALLEGATIONS REGARDING THE IMPLANTS. HARDWARE REMOVAL WAS COMPLETED SUCCESSFULLY WITH NO DELAYS. THE PATIENT IS DOING FINE POSTOPERATIVELY. THIS REPORT IS FOR ONE (1) 7.3MM CANNULATED SCREW 32MM THREAD/80MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 11858164 ↗
• InjuryMay 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, PATIENT UNDERWENT REMOVAL SURGERY OF HARDWARE DUE TO PAIN. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 7.3MM CANNULATED SCREW 32MM THREAD/80MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11806086 ↗
• MalfunctionMay 21, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A HARDWARE REMOVAL AS THE CANNULATED SCREW PULLED THROUGH THE WASHER AS EVIDENT IN THE PREOPERATIVE FILMS. THREE CANNULATED SCREWS AND WASHERS WERE REMOVED. THE SURGEON REMOVED THE CANNULATED SCREWS SO THAT A SPINE SURGEON COULD PERFORM A MULTI LEVEL LUMBAR/SACRAL FUSION. CONCOMITANT DEVICES REPORTED: CANNULATED SCREW (PART# 208.442, LOT# 9921917, QUANTITY 1), UNKNOWN CANNULATED SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), WASHER (PART# 219.99, LOT# 2L68359, QUANTITY 1), WASHER (PART# 219.99, LOT# 2L95943, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10080489 ↗