EXPEDIUM 179771095Recalls & reported problems
Medos International Sàrl · EXPEDIUM SPINE SYSTEM PRE-BENT SPINAL ROD 5.5 x 95mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034077673), received between Mar 26, 2020 and Jun 12, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Migration” (3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Migration3
Patient problems
- Pain3
- Ambulation or Postural Difficulties2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Autoimmune Disorder2
- Distress2
- Dysphagia/ Odynophagia2
- Fall2
- Fatigue2
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 12, 2026Migration
IT WAS REPORTED THROUGH LEGAL DOCUMENTATION, THE PATIENT SUSTAINED INJURIES DUE TO A CAR ACCIDENT ON (B)(6) 2020. SUBSEQUENTLY, ON (B)(6) 2020, PLAINTIFF THE UNDERWENT AN OCCIPUT-C3 POSTERIOR SPINAL FUSION WHERE BONE SCREWS AND TITANIUM RODS WERE PLACED IN HER CERVICAL SPINE. PATIENT HAD GOOD RECOVERY. ON (B)(6) 2020, PATIENT WAS SEEN AND X-RAYS LEFT THE IMPRESSION OF AN ¿INSTRUMENTED POSTERIOR SPINAL FUSION AND POSTERIOR DECOMPRESSION FROM THE OCCIPUT THROUGH C3 FOR MANAGEMENT OF CERVICAL SPINE FRACTURES.¿ ALSO, X-RAYS OF HER RIGHT SHOULDER SHOWED A CLAVICULAR FRACTURE AND THORACIC COMPRESSION FRACTURES AT THE T5 AND T6 LEVELS. PLAINTIFF WAS DIAGNOSED WITH A ¿CLOSED STABLE BURST FRACTURE OF FIRST CERVICAL VERTEBRAE WITH ROUTINE HEALING.¿ ON (B)(6) 2020 PATIENT WAS SEEN AND WAS NOTED DOING PHYSICAL THERAPY AND WAS IMPROVING. ON (B)(6) 2020 CT SCANS OF THE CERVICAL AND THORACIC SPINE SHOWED: OCCIPUT-C3 POSTERIOR BONE FUSION WITHOUT EVIDENCE FOR HARDWARE FAILURE¿ AND FRACTURES AT THE T3-T6 LEVELS. ON (B)(6) 2020, PATIENT WAS TREATED FOR PAIN MANAGEMENT AND WAS DIAGNOSED WITH CERVICALGIA AND PAIN IN THE THORACIC SPINE. ON (B)(6) 2020 PATIENT WAS SEEN AND X-RAYS OF THE CERVICAL AND THO
Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Autoimmune Disorder; Distress; Dysphagia/ Odynophagia; Fall; Fatigue; Headache; Laceration(s); Loss of Range of Motion; Nausea; Necrosis; Nerve Damage; Numbness; Pain; Physical Asymmetry; Speech Disorder; Unspecified Nervous System Problem
MAUDE report 25487188 ↗InjuryAug 28, 2024Migration; Migration
IT WAS REPORTED THROUGH LEGAL DOCUMENTATION, THE PATIENT SUSTAINED INJURIES DUE TO A CAR ACCIDENT ON (B)(6) 2020. SUBSEQUENTLY, ON (B)(6) 2020, PLAINTIFF THE UNDERWENT AN OCCIPUT-C3 POSTERIOR SPINAL FUSION WHERE BONE SCREWS AND TITANIUM RODS WERE PLACED IN HER CERVICAL SPINE. PATIENT HAD GOOD RECOVERY. ON (B)(6) 2020, PATIENT WAS SEEN AND X-RAYS LEFT THE IMPRESSION OF AN ¿INSTRUMENTED POSTERIOR SPINAL FUSION AND POSTERIOR DECOMPRESSION FROM THE OCCIPUT THROUGH C3 FOR MANAGEMENT OF CERVICAL SPINE FRACTURES.¿ ALSO, X-RAYS OF HER RIGHT SHOULDER SHOWED A CLAVICULAR FRACTURE AND THORACIC COMPRESSION FRACTURES AT THE T5 AND T6 LEVELS. PLAINTIFF WAS DIAGNOSED WITH A ¿CLOSED STABLE BURST FRACTURE OF FIRST CERVICAL VERTEBRAE WITH ROUTINE HEALING.¿ ON (B)(6) 2020 PATIENT WAS SEEN AND WAS NOTED DOING PHYSICAL THERAPY AND WAS IMPROVING. ON (B)(6) 2020 CT SCANS OF THE CERVICAL AND THORACIC SPINE SHOWED: OCCIPUT-C3 POSTERIOR BONE FUSION WITHOUT EVIDENCE FOR HARDWARE FAILURE¿ AND FRACTURES AT THE T3-T6 LEVELS. ON (B)(6) 2020, PATIENT WAS TREATED FOR PAIN MANAGEMENT AND WAS DIAGNOSED WITH CERVICALGIA AND PAIN IN THE THORACIC SPINE. ON (B)(6) 2020 PATIENT WAS SEEN AND X-RAYS OF THE CERVICAL AND THO
Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Autoimmune Disorder; Distress; Dysphagia/ Odynophagia; Fall; Fatigue; Headache; Laceration(s); Loss of Range of Motion; Nausea; Necrosis; Nerve Damage; Numbness; Pain; Physical Asymmetry; Speech Disorder; Unspecified Nervous System Problem
MAUDE report 20090205 ↗InjuryMar 26, 2020Migration; Migration
IT WAS REPORTED THE PATIENT UNDER A L3-S1 POSTERIOR FUSION WITH PLIFS SPINAL FUSION PROCEDURE ON (B)(6) 2019. POST-OPERATIVELY, THE SET SCREW OF RIGHT S1 BECAME DISLODGED; ADDITIONALLY, THE ROD HAS PULLED OUT OF LEFT S1 SCREW. THE PATIENT EXPERIENCED PAIN AND ON (B)(6) 2020 UNDERWENT A REVISION PROCEDURE. THE PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR AN EXPEDIUM ROD. THIS IS REPORT 4 OF 6 FOR (B)(4).
Patient problems: Failure of Implant; Pain
MAUDE report 9885469 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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