EXPEDIUM 196791385Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034295305), received between Aug 16, 2018 and Aug 4, 2020 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT THE T4-PELVIS PROCEDURE ON (B)(6) 2017. ON AN UNKNOWN POSTOPERATIVE DATE, THE PATIENT HAD PRESENTED TO THE SURGEON WITH PAIN AND IT WAS IDENTIFIED THAT THE RODS BROKE ON BOTH SIDES AT T10 AND T11. PATIENT HAS A SOLID FUSION. PATIENT UNDERWENT THE REVISION PROCEDURE ON (B)(6) 2020, WHERE BOTH RODS WERE REMOVED AND REPLACED. NO FURTHER INFORMATION IS PROVIDED. CONCOMITANT DEVICE REPORTED: SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); LOCKING/SET SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); ROD, 480 MM (PART #179762480, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) EXP5.5 385 MM CONTOUR COCR ROD. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10362517 ↗
• InjuryJan 20, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, REVISION SURGERY WAS DONE DUE TO SPINAL HARDWARE FAILURE, A BROKEN ROD ON THE LEFT SIDE AT THE REGION OF L5-S1. THE BROKEN ROD WAS EXPLANTED AND REPLACED. IT WAS INITIALLY IMPLANTED ON (B)(6) 2017. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SET SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) EXP5.5 385MM CONTOUR COCR ROD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9606647 ↗
• InjuryJul 29, 2019Break; Break

  REVISION T5-PELVIS: DR (B)(6), (B)(6) HOSPITAL, (B)(6) 2019. THE PATIENT HAD BILATERAL BROKEN RODS AT L3 OVER OLD PSO SITE. PATIENT HISTORY: ON (B)(6) 2014 PATIENT HAD REMOVAL OF HARRINGTON RODS - "POST HARRINGTON FLAT BACK", AND IMPLANTS PLACED, T5-PELVIS, WITH A CAGE INSERTED AT L5/S1. THERE WERE TEMPORARY RODS PLACED OVER THE CAGE, L5-S1,UNTIL THE STAGE 2 OPERATION WHEN THE FINAL RODS WILL BE PLACED ON (B)(6) 2014: STAGE 2. PSO (PEDICLE SUBTRACTION OSTEOTOMY) PERFORMED AT L3 AND THEN THE RODS AND SET SCREWS INSERTED FROM T5-PELVIS. THERE WERE ALSO, X 2 CROSS CONNECTORS PLACED ON THE CONSTRUCT. IN (B)(6) 2019: PATIENT HAD EXPERIENCED PAIN, WAS SEEN BY DR CREE AND X-RAYS TAKEN. SURGERY PLANNED TO REPLACE THE BROKEN RODS AND SET SCREWS. ON (B)(6) 2019: IN SURGERY, IT WAS NOTED THAT THERE WAS MOVEMENT WHERE THE OLD PSO SITE WAS, L3, "NON UNION" SO THE SET SCREWS AND RODS WERE REMOVED, SCREWS REPLACED AT L2, L4,L5 AND S1 AND THEN NEW RODS AND SET SCREWS PUT IN PLACE. HE ALSO PLACED AN "OUTRIGGER" CONSTRUCT, AT L3, ANOTHER ROD CONNECTED BY OPEN/CLOSED CONNECTORS, THAT RUN BESIDE THE TOTAL ROD LENGTH. FEMALE PATIENT INITIALS: (B)(6) YEARS OLD, DOB: (B)(6) 1955. THIS COMPLAINT INVOLVES

  Patient problems: No Code Available; Pain

  MAUDE report 8838024 ↗
• InjuryJul 26, 2019Break; Break

  REVISION T5-PELVIS : DR (B)(6) HOSPITAL, (B)(6) 2019. THE PATIENT HAD BILATERAL BROKEN RODS AT L3 OVER OLD PSO SITE. PATIENT HISTORY: ON (B)(6) 2014 PATIENT HAD REMOVAL OF HARRINGTON RODS - "POST HARRINGTON FLAT BACK", AND IMPLANTS PLACED, T5-PELVIS, WITH A CAGE INSERTED AT L5/S1. THERE WERE TEMPORARY RODS PLACED OVER THE CAGE, L5-S1,UNTIL THE STAGE 2 OPERATION WHEN THE FINAL RODS WILL BE PLACED. ON (B)(6) 2014: STAGE 2. PSO (PEDICLE SUBTRACTION OSTEOTOMY) PERFORMED AT L3 AND THEN THE RODS AND SET SCREWS INSERTED FROM T5-PELVIS. THERE WERE ALSO, X 2 CROSS CONNECTORS PLACED ON THE CONSTRUCT. ON (B)(6) 2019: PATIENT HAD EXPERIENCED PAIN, WAS SEEN BY DR CREE AND X-RAYS TAKEN. SURGERY PLANNED TO REPLACE THE BROKEN RODS AND SET SCREWS. ON (B)(6) 2019: IN SURGERY, IT WAS NOTED THAT THERE WAS MOVEMENT WHERE THE OLD PSO SITE WAS, L3, "NON UNION" SO THE SET SCREWS AND RODS WERE REMOVED, SCREWS REPLACED AT L2, L4,L5 AND S1 AND THEN NEW RODS AND SET SCREWS PUT IN PLACE. HE ALSO PLACED AN "OUTRIGGER" CONSTRUCT, AT L3, ANOTHER ROD CONNECTED BY OPEN/CLOSED CONNECTORS, THAT RUN BESIDE THE TOTAL ROD LENGTH. FEMALE PATIENT INITIALS: (B)(6) YEARS OLD, DOB:(B)(6) 1955. THIS COMPLAINT INVOLVES 2 DEVIC

  Patient problems: No Code Available; Pain

  MAUDE report 8831084 ↗
• InjuryAug 16, 2018Break; Break

  THE FOLLOWING WAS REPORTED: REVISION T3-PELVIS - BROKEN RODS; ANDREW CREE WESTMEAD PRIVATE HOSPITAL 31-7-2018. PRIMARY IMPLANT DATE: (B)(6) 2016. DR CREE WAS PERFORMING A REVISION SPINAL FUSION FOR BROKEN RODS AT L3/4 (R) AND L4/5 (L). AS STATED, THIS WAS DUE TO A PROBABLE NON-UNION. HE REMOVED THE SCREWS AND BROKEN RODS FROM L2-5 ON BOTH SIDES AND REPLACED THEM WITH NEW SCREWS AND RODS. HE THEN CONNECTED THE NEW RODS TO THE PROXIMAL FUSION BY USING CONNECTORS ON BOTH SIDES.

  Patient problems: No Code Available; Not Applicable; Spinal Column Injury

  MAUDE report 7790473 ↗