EXPEDIUM 179732645Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034073873), received between Aug 6, 2019 and Feb 14, 2024 — classified as 2 injuries, 2 malfunctions.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 14, 2024Migration; Migration

  IT WAS REPORTED THE PATIENT HAD A SPINE CONSTRUCT IMPLANTED (B)(6) 2023 FROM T10 TO PELVIS. THE PATIENT WAS IMPLANTED WITH 2 EXPEDIUM RODS, AN UNKNOWN NUMBER VIPER AND EXPEDIUM SCREWS, AND TWO PELVIC SCREWS. PATIENT WAS EXPERIENCING PAIN AND HAD A FOLLOW UP (B)(6) 2023. DURING THE FOLLOW UP IMAGES IDENTIFIED 2 BROKEN RODS AND AN UNKNOWN NUMBER OF MIGRATED SCREWS. THE PATIENT WILL BE HAVING A REVISION SURGERY ON (B)(6) 2024. THIS REPORT IS FOR ONE (1) UNK - MONO/POLYAXIAL SCREWS: VIPER THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 18703292 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT AN UNKNOWN SURGERY FOR ADOLESCENT IDIOPATHIC SCOLIOSIS WAS COMPLETED ON (B)(6) 2022. AFTER THE SURGERY, ON (B)(6) 2023, AN INFECTION WAS CONFIRMED ON CONCAVE SIDE. REVISION SURGERY OCCURRED ON (B)(6) 2023. DURING THE REVISION, THE SET SCREWS ON T2·3·4·5 ON THE LEFT WERE REMOVED. THE ROD WHERE THE SET SCREWS WERE REMOVED WERE CUT BY THE T-SAW. THE RODS WERE REMOVED. FOUR OF THE UNIPLANAR SCREWS (5.0 DIAMETER 30MM LONG) ON THE LEFT T2-T5 WERE REMOVED. THE AFFECTED AREA WAS WASHED. THE HOOK WAS PLACED ON T2 (WIDE BLADE/THROAT 10). SIDE-SIDE CONNECTOR INSTALLED AT THE UPPER END OF T5. TITANIUM ROD CONNECTION WAS PERFORMED BETWEEN T2 AND T5. THE WOUND WAS CLOSED. THIS REPORT IS FOR ONE EXPEDIUM SPINE SYSTEM SI POLYAXIAL EXTEND TAB 5.5 X 6 X 45MM FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18502323 ↗
• MalfunctionAug 6, 2019Break; Break

  EXPEDIUM 5.5 TITANIUM SCREWS: 1797-32-645 - 4 PIECES. REASON FOR CONTACT: INTRAOPERATIVELY, WHILE TIGHTENING THE REDUCTION SCREW WITH A NUT-SCREW, THE TUNING FORKS OF THE TWO SCREWS PREMATURELY BROKE OFF. THE INCIDENT WAS REPORTED TO THE OPERATING SURGEON. DATE / TIME OF THE INCIDENT: (B)(6) 2019 13:00. DATE / TIME WHEN J & J EMPLOYEE BECAME AWARE OF THE INCIDENT: JULY 15, 2019 13:00. CONCOMITANT DEVICE REPORTED: SI POLYAXL EXT TAB 6 X 45MM (PART# 179732645, LOT# UNKNOWN, QUANTITY 2). THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8865408 ↗
• MalfunctionAug 6, 2019Break; Break

  EXPEDIUM 5.5 TITANIUM SCREWS. 1797-32-645 - 4 PIECES. REASON FOR CONTACT: INTRAOPERATIVELY, WHILE TIGHTENING THE REDUCTION SCREW WITH A NUT-SCREW, THE TUNING FORKS OF THE TWO SCREWS PREMATURELY BROKE OFF. THE INCIDENT WAS REPORTED TO THE OPERATING SURGEON. DATE / TIME OF THE INCIDENT: (B)(6) 2019 13:00. DATE / TIME WHEN J & J EMPLOYEE BECAME AWARE OF THE INCIDENT: JULY 15, 2019 13:00 PHOTOS OF PRODUCTS ATTACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8865395 ↗