EXPEDIUM 179702745Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034065052), received between Nov 8, 2017 and Nov 8, 2017 — classified as 2 injuries.

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

• InjuryNov 8, 2017Break; Break

  NON UNION AT L3/BROKEN SCREW - ANTERIOR SCOLIOSIS PSF. CONGENITAL SCOLIOSIS. REVISION OF THE ANTERIOR FUSION (T11-L3) OF AN ANTERIOR/POSTERIOR SCOLIOSIS FUSION. ORIGINAL SURGERY PERFORMED IN 2007. PATIENT PRESENTED WITH A NON UNION AT L3 AND A BROKEN SCREW AT L3. THE SURGEON IS NOT SURE WHICH OCCURRED 1ST. THE BROKEN HEAD OF THE SCREW, MONOAXIAL SCREW AT L2, SINGLE STAPLE (X 1), SET SCREWS (X5) AND SINGLE ROD WERE REMOVED. THE SURGEON WAS UNABLE TO REMOVE THE SHAFT OF THE SCREW AT L3. SCREW REMOVED AND REPLACED AT L2 AND THEN PLACED ANOTHER SCREW, BESIDE L2 AND L3. A ROD WAS THEN PLACED IN T11-L3 AND IN THE NEW SCREWS, L2 AND L3. HE ALSO PLACED A MESH CAGE IN THE DISC SPACE BETWEEN L2 AND L3 TO ASSIST WITH SCOLIOSIS.

  Patient problems: Failure of Implant; Injury; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7008983 ↗
• InjuryNov 8, 2017Break; Break

  NON UNION AT L3/BROKEN SCREW - ANTERIOR SCOLIOSIS PSF. CONGENITAL SCOLIOSIS. REVISION OF THE ANTERIOR FUSION (T11-L3) OF AN ANTERIOR/POSTERIOR SCOLIOSIS FUSION. ORIGINAL SURGERY PERFORMED IN 2007. PATIENT PRESENTED WITH A NON UNION AT L3 AND A BROKEN SCREW AT L3. THE SURGEON IS NOT SURE WHICH OCCURRED 1ST. THE BROKEN HEAD OF THE SCREW, MONOAXIAL SCREW AT L2, SINGLE STAPLE (X 1), SET SCREWS (X5) AND SINGLE ROD WERE REMOVED. THE SURGEON WAS UNABLE TO REMOVE THE SHAFT OF THE SCREW AT L3. SCREW REMOVED AND REPLACED AT L2 AND THEN PLACED ANOTHER SCREW, BESIDE L2 AND L3. A ROD WAS THEN PLACED IN T11-L3 AND IN THE NEW SCREWS, L2 AND L3. HE ALSO PLACED A MESH CAGE IN THE DISC SPACE BETWEEN L2 AND L3 TO ASSIST WITH SCOLIOSIS. PHOTOS OF X-RAYS, EXPLANTED IMPLANTS AND POST OP PHOTO OF THE X-RAY.

  Patient problems: Failure of Implant; Injury; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7008970 ↗