EXPEDIUM 179715645Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034068589), received between Dec 6, 2017 and Jun 23, 2026 — classified as 6 injuries.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

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

  IN (B)(6) 2020, THE PATIENT WAS INVOLVED IN A CAR COLLISION AND WAS AIRLIFTED TO (B)(6). THE PATIENT HAD ORIGINAL SURGERY IN (B)(6) 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 VERTEBRAE WITH ROUTINE HEALING. ON (B)(6

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

  MAUDE report 25593554 ↗
• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  IN (B)(6) 2020, THE PATIENT WAS INVOLVED IN A CAR COLLISION AND WAS AIRLIFTED TO(B)(6)MEDICAL CENTER IN (B)(6), TEXAS. THE PATIENT HAD ORIGINAL SURGERY IN (B)(6) 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) AIRFORCE BASE 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 CERV

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

  MAUDE report 25593478 ↗
• 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)(60 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intervertebral Disc Compression or Protrusion

  MAUDE report 20087615 ↗
• 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 (B)(6) THE PATIENT WAS MORE LETHARGIC BUT BY DOCUMENTATION SEEMED TO HAVE A FLUCTUATING LEVEL OF AROUSAL/ALERTNESS AND SOME DISORIENTATION. STARTING (B)(6) AND INTO (B)(6) 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 (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 BETWEEN

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bone Fracture(s); Deformity/ Disfigurement; Fluid Discharge; Nonunion/Delayed-union Bone Fracture; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury

  MAUDE report 20078083 ↗
• InjuryDec 6, 2017Break; Break

  DURING A REVISION TO EXTEND THE FUSION UP ONE LEVEL IT WAS DISCOVERED THE S1 SCREW HAD BROKE. 179715645. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: Spinal Column Injury

  MAUDE report 7088322 ↗
• InjuryDec 6, 2017Break; Break

  WHEN EXTENDING A FUSION FROM L4UP TO L3 WE DISCOVERED THE SCREWIN S1WASBROKEN PATIENT CONSEQUENCE? :NO. ACTION TAKEN FOR PROCEDURE:LEFT S1 SCREW. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: Spinal Column Injury

  MAUDE report 7088096 ↗