EXPEDIUM 179762045Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034077314), received between Jul 22, 2022 and Nov 2, 2023 — classified as 4 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 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.

• InjuryNov 2, 2023Adverse 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 THERE WAS POSTERIOR LUMBAR INTERBODY FUSION (L4/5) PERFORMED ON (B)(6) 2014. AFTER THE SURGERY, ASD OCCURRED. THE REOPERATION TO EXTEND FIXATION WILL BE PERFORMED ON (B)(6) 2023. THE EXP SINGLE INNER SETSCREW, MMSI ROD AND SFX 5.5 TRANSV CONN 49-66 MM IN QUESTION WILL BE REPLACED. 5.5 CANNULATED CORTICAL FIX SCREW 6X40MM AND CONC BULLET PARALLEL IN QUESTION WILL BE PRESERVED. THE EXTENSION SURGERY (L/S2) WILL BE PERFORMED WITH ALAR ILIAC, OLIF WILL BE PERFORMED FOR L2/3 AND L3/. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM ROD 5.5 X 45MM. THIS IS REPORT 6 OF 10 FOR (B)(4). THIS PRODUCT COMPLAINT, (B)(4), IS RELATED TO (B)(4).

  Patient problems: Osteolysis

  MAUDE report 18055321 ↗
• InjuryNov 2, 2023Adverse 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 THERE WAS POSTERIOR LUMBAR INTERBODY FUSION (L4/5) PERFORMED ON (B)(6) 2014. AFTER THE SURGERY, ASD OCCURRED. THE REOPERATION TO EXTEND FIXATION WILL BE PERFORMED ON (B)(6) 2023. THE EXP SINGLE INNER SETSCREW, MMSI ROD AND SFX 5.5 TRANSV CONN 49-66 MM IN QUESTION WILL BE REPLACED. 5.5 CANNULATED CORTICAL FIX SCREW 6X40MM AND CONC BULLET PARALLEL IN QUESTION WILL BE PRESERVED. THE EXTENSION SURGERY (L/S2) WILL BE PERFORMED WITH ALAR ILIAC, OLIF WILL BE PERFORMED FOR L2/3 AND L3/. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM ROD 5.5 X 45MM. THIS IS REPORT 7 OF 10 FOR (B)(4). THIS PRODUCT COMPLAINT, (B)(4), IS RELATED TO (B)(4).

  Patient problems: Osteolysis

  MAUDE report 18055319 ↗
• InjuryMar 30, 2023Adverse 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 THE PATIENT UNDERWENT A SPINAL FUSION (L3/4) ON (B)(6) 2014. AFTER SURGERY, ADJACENT INTERVERTEBRAL DISORDER OCCURRED AT L2/3 AND L4/5. ON (B)(6), 2023, A REOPERATION WAS PERFORMED. IN THE REOPERATION, SET SCREWS AND RODS OF L3/4 WERE REMOVED, AND SCREWS WERE ADDED TO L2 AND L5. TLIF TREATING L2/3 AND TLIF TREATING L4/5 WERE DONE. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THERE IS NO PROBLEM IN THE FUSION SITE TREATED IN THE INITIAL SURGERY IN 2024. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM ROD 5.5 X 45MM. THIS IS REPORT 5 OF 7 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 16644043 ↗
• InjuryMar 30, 2023Adverse 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 THE PATIENT UNDERWENT A SPINAL FUSION (L3/4) ON (B)(6) 2014. AFTER SURGERY, ADJACENT INTERVERTEBRAL DISORDER OCCURRED AT L2/3 AND L4/5. ON (B)(6) 2023, A REOPERATION WAS PERFORMED. IN THE REOPERATION, SET SCREWS AND RODS OF L3/4 WERE REMOVED, AND SCREWS WERE ADDED TO L2 AND L5. TLIF TREATING L2/3 AND TLIF TREATING L4/5 WERE DONE. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THERE IS NO PROBLEM IN THE FUSION SITE TREATED IN THE INITIAL SURGERY IN 2024. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM ROD 5.5 X 45MM. THIS IS REPORT 2 OF 7 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 16644038 ↗
• MalfunctionJul 22, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A PLIF (L4-5) FOR TREATING SPONDYLOLISTHESIS ON (B)(6) 2022. THE 7.0X 40MM SCREW (UNK) CUT OUT DURING SCREW TIGHTENING (WIPER MOTION) WITH THE TORQUE WRENCH IN QUESTION. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT (7.0X 45MM SCREW) LESS THAN 30-MINUTE SURGICAL DELAY. HE COMMENTED THAT THE EVENT MIGHT HAVE BEEN TRIGGERED BY MALFUNCTIONING TORQUE-VALUE SETTING ON THE TORQUE WRENCH. IT WAS BECAUSE AN EXCESSIVE LOAD HAD BEEN UNEXPECTEDLY PUT ONTO THE SCREW. WHEN THE SURGEON WAS APPLYING THE REPLACEMENT, HE ALSO FELT STRONG LOAD EVEN BEFORE TORQUE CAME INTO ACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) MMSI ROD, 5.5 X 45MM, TI. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15085913 ↗