EXPEDIUM 179762050Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034077321), received between Jun 15, 2022 and Jun 15, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (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.

• InjuryJun 15, 2022Migration; Migration

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO A MIGRATED ROD. THE SURGEON PLANS TO REPLACE SCREW, ROD, AND SETSCREWS. THE SETSCREW ON THE L3 LEFT HAD THOROUGHLY COME OFF. THE SETSCREW ON THE L3 RIGHT WAS LOOSE. THE RODS HAD COME OFF THE LESION. THE SCREWS ON BOTH SIDES (HAD BEEN SECURED IN THE LESION. THE SETSCREWS, THE RODS, AND THE SCREWS WERE REPLACED WITHOUT ISSUE. PATIENT ORIGINALLY UNDERWENT A PRIMARY PLIF PROCEDURE (L3/4) ON (B)(6) 2022. POSTOPERATIVE X-RAYS SHOWED NO ISSUE. ON (B)(6) 2022, PATIENT WAS X-RAYED AGAIN, AND IMAGES CONFIRMED THAT A ROD HAD COME OFF THE LESION WHILE SETSCREWS HAD BEEN TIGHTENED IN PLACE. THIS REPORT IS FOR A MOSS MIAMI ROD 5.5X50MM TI. THIS IS REPORT 4 OF 4 FOR (B)(4).

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

  MAUDE report 14697589 ↗
• InjuryJun 15, 2022Migration; Migration

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO A MIGRATED ROD. THE SURGEON PLANS TO REPLACE SCREW, ROD, AND SETSCREWS. THE SETSCREW ON THE L3 LEFT HAD THOROUGHLY COME OFF. THE SETSCREW ON THE L3 RIGHT WAS LOOSE. THE RODS HAD COME OFF THE LESION. THE SCREWS ON BOTH SIDES (HAD BEEN SECURED IN THE LESION. THE SETSCREWS, THE RODS, AND THE SCREWS WERE REPLACED WITHOUT ISSUE. PATIENT ORIGINALLY UNDERWENT A PRIMARY PLIF PROCEDURE (L3/4) ON (B)(6) 2022. POSTOPERATIVE X-RAYS SHOWED NO ISSUE. ON (B)(6) 2022, PATIENT WAS X-RAYED AGAIN, AND IMAGES CONFIRMED THAT A ROD HAD COME OFF THE LESION WHILE SETSCREWS HAD BEEN TIGHTENED IN PLACE. THIS REPORT IS FOR A MOSS MIAMI ROD 5.5X50MM TI. THIS IS REPORT 1 OF 4 FOR (B)(4).

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

  MAUDE report 14696579 ↗