EXPEDIUM 179715535Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034068398), received between Aug 27, 2024 and Jun 23, 2026 — classified as 3 injuries.

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  IN FEBRUARY 2020, THE PATIENT WAS INVOLVED IN A CAR COLLISION AND WAS AIRLIFTED TO UNIVERSITY MEDICAL CENTER IN LUBBOCK, TEXAS. THE PATIENT HAD ORIGINAL SURGERY IN FEBRUARY 2020. THE ORIGINAL SURGERY DID NOT INVOLVE ANY SYNTHES DEVICES. DUE TO IMPLANT FAILURES THE PATIENT HAD ADDITIONAL SURGERIES WHICH INVOLVED ADDING SYNTHES DEVICES TO THE COMPETITOR PRODUCTS THAT WERE INITIALLY PLACED. ON (B)(6) 2020, THE PATIENT UNDERWENT AN OCCIPUT-C3 POSTERIOR SPINAL FUSION WHERE BONE SCREWS AND TITANIUM RODS WERE PLACED IN HER CERVICAL SPINE. THE PROCEDURE WAS PERFORMED PURSUANT TO THE STANDARD OF CARE AND PATIENT TOLERATED THE PROCEDURE WELL. PATIENT'S PHYSICAL AND MENTAL HEALTH IMPROVED GREATLY AFTER THIS SURGERY. ON (B)(6) 2020, THE PATIENT INFORMED (B)(6) ABOUT THE VEHICULAR COLLISION AND REQUESTED PAIN MANAGEMENT. ON (B)(6) 2020, 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 HER RIGHT SHOULDER SHOWED CLAVICULAR FRACTURE AND THORACIC COMPRESSION FRACTURES AT THE T5 AND T6 LEVELS. PATIENT WAS DIAGNOSED WITH A CLOSED STABLE BURST FRACTURE OF FIRST CERVICAL

  Patient problems: Bone Fracture(s); Depression; Fatigue; Impaired Healing; Inflammation; Loss of Range of Motion; Numbness; Pain; Thrombosis/Thrombus; Unspecified Tissue Injury

  MAUDE report 25593129 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 IT WAS NOTED THAT SINCE SURGERY AND EXTUBATION, THE PATIENT'S MENTAL STATUS HAS BEEN ALTERED. INITIALLY (B)(6) THE PATIENT WAS MORE LETHARGIC BUT BY DOCUMENTATION SEEMED TO HAVE A FLUCTUATING LEVEL OF AROUSAL/ALERTNESS AND SOME DISORIENTATION. STARTING JULY 9 AND INTO JULY 10, THE PATIENT HAS HAD PROGRESSIVE WORSENING OF AGITATION, SLEEP DISTURBANCE, AND DISORIENTATION, AS WELL AS NEW HALLUCINATIONS, ILLUSIONS AND DELUSIONS. DURING THIS PERIOD THE PATIENT'S MENTAL STATUS WAS WAXING AND WANING. ON JULY 18, 2020 THE PATIENT WAS RELEASED FROM THE HOSPITAL. ON (B)(6) 2020, X-RAYS WERE TAKEN WHICH SHOWED MULTIPLE THORACIC BURST/COMPRESSION FRACTURES, MOST SEVERE AT T6. ON (B)(6) 2020 THE SURGEON NOTED THAT: SHE DID FAIRLY WELL EARLY ON REGAINING SOME OF HER NEUROLOGIC FUNCTION SHE HAD LOST THROUGH PHYSICAL THERAPY BUT THEN HAD COLLAPSE THROUGH HER MIDTHORACIC SPINE. ON (B)(6) 2020 THE SURGEON NOTED THAT: WE INITIALLY INTERVENED TO STOP THE COLLAPSE OF HER THORACIC FRACTURES BY FUSING HER FROM T3-T9. SHE DID WELL INITIALLY AND THEN QUICKLY HER SOFT TISSUES HAD HER CERVICOTHORACIC JUNCTION FAILED. THIS LEFT US NO CHOICE BUT TO INTERVENE BY FUSING BETWEE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Nonunion/Delayed-union Bone Fracture; Unspecified Infection; Unspecified Mental, Emotional or Behavioral Problem; Vertebral Fracture

  MAUDE report 20077821 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON JULY 13, 2020 IT WAS NOTED THAT SINCE SURGERY AND EXTUBATION, THE PATIENT'S MENTAL STATUS HAS BEEN ALTERED. INITIALLY JULY 7 - JULY 8 THE PATIENT WAS MORE LETHARGIC BUT BY DOCUMENTATION SEEMED TO HAVE A FLUCTUATING LEVEL OF AROUSAL/ALERTNESS AND SOME DISORIENTATION. STARTING JULY 9 AND INTO JULY 10, THE PATIENT HAS HAD PROGRESSIVE WORSENING OF AGITATION, SLEEP DISTURBANCE, AND DISORIENTATION, AS WELL AS NEW HALLUCINATIONS, ILLUSIONS AND DELUSIONS. DURING THIS PERIOD THE PATIENT'S MENTAL STATUS WAS WAXING AND WANING. ON (B)(6) 2020 THE PATIENT WAS RELEASED FROM THE HOSPITAL. ON AUGUST 18, 2020, X-RAYS WERE TAKEN WHICH SHOWED MULTIPLE THORACIC BURST/COMPRESSION FRACTURES, MOST SEVERE AT T6. ON SEPTEMBER 25, 2020 THE SURGEON NOTED THAT: SHE DID FAIRLY WELL EARLY ON REGAINING SOME OF HER NEUROLOGIC FUNCTION SHE HAD LOST THROUGH PHYSICAL THERAPY BUT THEN HAD COLLAPSE THROUGH HER MIDTHORACIC SPINE. ON OCTOBER 27, 2020 THE SURGEON NOTED THAT: WE INITIALLY INTERVENED TO STOP THE COLLAPSE OF HER THORACIC FRACTURES BY FUSING HER FROM T3-T9. SHE DID WELL INITIALLY AND THEN QUICKLY HER SOFT TISSUES HAD HER CERVICOTHORACIC JUNCTION FAILED. THIS LEFT US NO CHOICE BUT TO I

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Nonunion/Delayed-union Bone Fracture; Unspecified Infection; Unspecified Mental, Emotional or Behavioral Problem; Vertebral Fracture

  MAUDE report 20077734 ↗