EXPEDIUM 179702000Recalls & reported problems

Summary

The FDA's MAUDE database contains 439 adverse event reports that list this exact device (DI 10705034064307), received between Apr 30, 2014 and Sep 17, 2026 — classified as 323 injuries, 116 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (89 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 439 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Device Slipped

  Patient problems: Insufficient Information

  MAUDE report 50808477 ↗
• 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). 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) AT (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 VERTE

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

  MAUDE report 25592374 ↗
• 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 375TH MEDICAL GROUP AT SCOTT 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 CERVICAL VERT

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

  MAUDE report 25592366 ↗
• 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 UNIVERSITY MEDICAL CENTER IN LUBBOCK, 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 375TH MEDICAL GROUP AT SCOTT 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

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

  MAUDE report 25592328 ↗
• InjuryJun 19, 2026Break

  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 (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 PATIENT DID FAIRLY WELL EARLY ON REGAINING SOME OF HER NEUROLOGIC FUNCTION. PATIENT 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 B

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Deformity/ Disfigurement; Fluid Discharge; Nonunion/Delayed-union Bone Fracture; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury

  MAUDE report 25566004 ↗
• InjuryJun 19, 2026Break

  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 (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 PATIENT DID FAIRLY WELL EARLY ON REGAINING SOME OF HER NEUROLOGIC FUNCTION. PATIENT 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 THE 2 PRI

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Deformity/ Disfigurement; Fluid Discharge; Nonunion/Delayed-union Bone Fracture; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury

  MAUDE report 25566000 ↗
• InjuryJun 19, 2026Break

  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 (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 PATIENT DID FAIRLY WELL EARLY ON REGAINING SOME OF HER NEUROLOGIC FUNCTION. PATIENT 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 THE 2 PRI

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Deformity/ Disfigurement; Fluid Discharge; Nonunion/Delayed-union Bone Fracture; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury

  MAUDE report 25565980 ↗
• InjuryJun 19, 2026Break

  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 (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 PATIENT DID FAIRLY WELL EARLY ON REGAINING SOME OF HER NEUROLOGIC FUNCTION. PATIENT 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 B

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Deformity/ Disfigurement; Fluid Discharge; Nonunion/Delayed-union Bone Fracture; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury

  MAUDE report 25565974 ↗
• InjuryJun 19, 2026Adverse Event Without Identified Device or Use Problem

  IN FEBRUARY 2020, THE PATIENT WAS INVOLVED IN A CAR COLLISION AND WAS AIRLIFTED TO (B)(6) IN (B)(6). 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 M(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) 2020, IT WAS NOTED THAT THE PATIENT WAS UNDERGOING PHYSICAL THERAPY AND IMPROVING. ON (B)(6) 2020, CT SCANS OF THE CERVICAL AND THORACIC SPINE SHOWED: OCCIPUT-C3 POSTERIOR INSTRUMENTED FUSION WITHOUT EVIDENCE FOR HARDWARE FAILURE, AND FRACTURES A

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

  MAUDE report 25564723 ↗
• InjuryJun 19, 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) IN (B)(6). 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) 2020, IT WAS NOTED THAT THE PATIENT WAS UNDERGOING PHYSICAL THERAPY AND IMPROVING. ON (B)(6) 2020, CT SCANS OF THE CERVICAL AND THORACIC SPINE SHOWED: OCCIPUT-C3 POSTERIOR INSTRUMENTED FUSION WITHOUT EVIDENCE FOR HARDWARE FAILURE, AND FRACTURES AT T

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

  MAUDE report 25564720 ↗
• InjuryJun 19, 2026Adverse Event Without Identified Device or Use Problem

  IN (B)(4) 2020, THE PATIENT WAS INVOLVED IN A CAR COLLISION AND WAS AIRLIFTED TO (B)(6) IN (B)(6). 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) 2020, IT WAS NOTED THAT THE PATIENT WAS UNDERGOING PHYSICAL THERAPY AND IMPROVING. ON (B)(6) 2020, CT SCANS OF THE CERVICAL AND THORACIC SPINE SHOWED: OCCIPUT-C3 POSTERIOR INSTRUMENTED FUSION WITHOUT EVIDENCE FOR HARDWARE FAILURE, AND FRACTURES AT T

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

  MAUDE report 25564680 ↗
• InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem

  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 ¿[I]NSTRUMENTED 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 AN

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 25487709 ↗
• MalfunctionJan 16, 2026Break; Material Deformation

  IT WAS REPORTED THAT DURING A L2 VERTEBRAL FRACTURE OPEN REDUCTION AND INTERNAL FIXATION SURGERY, THE WIRE ON THE OUTER RING OF THE DEVICE WAS DEFORMED AND BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24096279 ↗
• MalfunctionJan 16, 2026Break; Material Deformation

  IT WAS REPORTED THAT DURING A L2 VERTEBRAL FRACTURE OPEN REDUCTION AND INTERNAL FIXATION SURGERY, THE WIRE ON THE OUTER RING OF THE DEVICE WAS DEFORMED AND BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24096277 ↗
• MalfunctionJan 12, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT PATIENT UNDERWENT POSTERIOR SPINAL FUSION(T3) FOR AIS ON (B)(6) 2025. THE SET SCREW WAS PLACED DURING SURGERY, AND WHEN THE SURGEON TRIED TO LOOSEN IT FOR CORRECTIVE PURPOSES, IT SPUN FREELY AND COULD NOT BE LOOSENED. UPON REMOVING THE SCREW AND CHECKING, IT WAS FOUND THAT THE THREADS ON THE SET SCREW WERE DAMAGED. THE SCREW WAS REPLACED AND A NEW SET SCREW WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24045153 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, PATIENT UNDERWENT L5-S1 CENTRAL DECOMPRESSION SURGERY WITH BILATERAL L5-S1 NERVE ROOT DECOMPRESSION, L5-S1 POSTERIOR SPINAL FUSION, AND L5-SI POSTERIOR SPINAL SEGMENTAL INSTRUMENTATION. AS PART OF THIS PROCEDURE, PATIENT WAS IMPLANTED WITH EXPEDIUM PEDICLE SCREWS. AT A POST-OPERATIVE VISIT WITH HIS SURGEON ON (B)(6) 2024, PATIENT REPORTED THAT ABOUT TWO WEEKS PRIOR TO THE VISIT HE FELT A POP IN HIS LOW BACK WHEN HE STEPPED AROUND AN OBJECT. AN X-RAY TAKEN AT THE (B)(6) 2024, POST-OP VISIT SHOWED THAT THE LEFT L4 PEDICLE SCREW WAS FRACTURED "AT THE BASE OF THE MULTIAXIAL CONNECTOR." BASED ON THE HOPE THAT THE FUSION WOULD NEVERTHELESS "PROCEED TO FULL CONSOLIDATION," PATIENT'S SURGEON RECOMMENDED NO SURGICAL INTERVENTION AT THAT TIME. (THE SURGEON CORRECTED HIS ANATOMICAL NOMENCLATURE TO L5 IN A SUBSEQUENT VISIT OF (B)(6) 2024, CONSISTENT WITH HIS OPERATIVE REPORT OF (B)(6) 2024.) AT A POST-OPERATIVE VISIT WITH HIS SURGEON ON (B)(6) 2024, X-RAYS SHOWED THAT THE ANTERIOR DISPLACEMENT OF HIS L4 VERTEBRA ON THE L5 VERTEBRA HAD INCREASED FROM 3 MM (AS OF THE (B)(6) 2024 VISIT) TO 9 MM. CONTINUED OBSERVATION WAS AGAIN RECOMMENDED BY PATIENT'S SURGEON. (THE SURGEON CORRECT

  Patient problems: Pain

  MAUDE report 24012512 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, PATIENT UNDERWENT L5-S1 CENTRAL DECOMPRESSION SURGERY WITH BILATERAL L5-S1 NERVE ROOT DECOMPRESSION, L5-S1 POSTERIOR SPINAL FUSION, AND L5-SI POSTERIOR SPINAL SEGMENTAL INSTRUMENTATION. AS PART OF THIS PROCEDURE, PATIENT WAS IMPLANTED WITH EXPEDIUM PEDICLE SCREWS. AT A POST-OPERATIVE VISIT WITH HIS SURGEON ON (B)(6) 2024, PATIENT REPORTED THAT ABOUT TWO WEEKS PRIOR TO THE VISIT HE FELT A POP IN HIS LOW BACK WHEN HE STEPPED AROUND AN OBJECT. AN X-RAY TAKEN ON (B)(6) 2024, POST-OP VISIT SHOWED THAT THE LEFT L4 PEDICLE SCREW WAS FRACTURED "AT THE BASE OF THE MULTIAXIAL CONNECTOR." BASED ON THE HOPE THAT THE FUSION WOULD NEVERTHELESS "PROCEED TO FULL CONSOLIDATION," PATIENT'S SURGEON RECOMMENDED NO SURGICAL INTERVENTION AT THAT TIME. (THE SURGEON CORRECTED HIS ANATOMICAL NOMENCLATURE TO L5 IN A SUBSEQUENT VISIT ON (B)(6) 2024, CONSISTENT WITH HIS OPERATIVE REPORT ON (B)(6) 2024.) AT A POST-OPERATIVE VISIT WITH HIS SURGEON ON (B)(6) 2024, X-RAYS SHOWED THAT THE ANTERIOR DISPLACEMENT OF HIS L4 VERTEBRA ON THE L5 VERTEBRA HAD INCREASED FROM 3 MM (AS OF ON (B)(6) 2024 VISIT) TO 9 MM. CONTINUED OBSERVATION WAS AGAIN RECOMMENDED BY PATIENT'S SURGEON. (THE SURGEON CORRECTED HI

  Patient problems: Pain

  MAUDE report 24011874 ↗
• InjuryJan 8, 2026Break

  ON (B)(6) 2024, PATIENT UNDERWENT L5-S1 CENTRAL DECOMPRESSION SURGERY WITH BILATERAL L5-S1 NERVE ROOT DECOMPRESSION, L5-S1 POSTERIOR SPINAL FUSION, AND L5-SI POSTERIOR SPINAL SEGMENTAL INSTRUMENTATION. AS PART OF THIS PROCEDURE, PATIENT WAS IMPLANTED WITH EXPEDIUM PEDICLE SCREWS. AT A POST-OPERATIVE VISIT WITH HIS SURGEON ON (B)(6) 2024, PATIENT REPORTED THAT ABOUT TWO WEEKS PRIOR TO THE VISIT HE FELT A POP IN HIS LOW BACK WHEN HE STEPPED AROUND AN OBJECT. AN X-RAY TAKEN ON (B)(6) 2024, POST-OP VISIT SHOWED THAT THE LEFT L4 PEDICLE SCREW WAS FRACTURED "AT THE BASE OF THE MULTIAXIAL CONNECTOR." BASED ON THE HOPE THAT THE FUSION WOULD NEVERTHELESS "PROCEED TO FULL CONSOLIDATION," PATIENT'S SURGEON RECOMMENDED NO SURGICAL INTERVENTION AT THAT TIME. (THE SURGEON CORRECTED HIS ANATOMICAL NOMENCLATURE TO L5 IN A SUBSEQUENT VISIT ON (B)(6) 2024, CONSISTENT WITH HIS OPERATIVE REPORT ON (B)(6) 2024.) AT A POST-OPERATIVE VISIT WITH HIS SURGEON ON (B)(6) 2024, X-RAYS SHOWED THAT THE ANTERIOR DISPLACEMENT OF HIS L4 VERTEBRA ON THE L5 VERTEBRA HAD INCREASED FROM 3 MM (AS OF ON (B)(6) 2024 VISIT) TO 9 MM. CONTINUED OBSERVATION WAS AGAIN RECOMMENDED BY PATIENT'S SURGEON. (THE SURGEON CORRECTED HI

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 24011441 ↗
• InjuryNov 17, 2025Break; Break

  ON (B)(6) 2024, PATIENT UNDERWENT L5-S1 CENTRAL DECOMPRESSION SURGERY WITH BILATERAL L5-S1 NERVE ROOT DECOMPRESSION, L5-S1 POSTERIOR SPINAL FUSION, AND L5-SI POSTERIOR SPINAL SEGMENTAL INSTRUMENTATION. AS PART OF THIS PROCEDURE, PATIENT WAS IMPLANTED WITH EXPEDIUM PEDICLE SCREWS. AT A POST-OPERATIVE VISIT ON (B)(6) 2024, PATIENT REPORTED THAT ABOUT TWO WEEKS PRIOR TO THE VISIT THEY FELT A POP IN THEIR LOW BACK WHEN THEY STEPPED AROUND AN OBJECT. AN X-RAY TAKEN ON (B)(6) 2024, POST-OP VISIT SHOWED THAT THE LEFT L4 PEDICLE SCREW WAS FRACTURED AT THE BASE OF THE MULTIAXIAL CONNECTOR. BASED ON THE HOPE THAT THE FUSION WOULD NEVERTHELESS "PROCEED TO FULL CONSOLIDATION," PATIENT'S SURGEON RECOMMENDED NO SURGICAL INTERVENTION AT THAT TIME. (THE SURGEON CORRECTED ANATOMICAL NOMENCLATURE TO L5 IN A SUBSEQUENT VISIT ON (B)(6) 2024, CONSISTENT WITH OPERATIVE REPORT ON (B)(6) 2024.). AT A POST-OPERATIVE VISIT ON (B)(6) 2024, X-RAYS SHOWED THAT THE ANTERIOR DISPLACEMENT OF THE L4 VERTEBRA ON THE L5 VERTEBRA HAD INCREASED FROM 3 MM (AS ON (B)(6) 2024 VISIT) TO 9 MM. CONTINUED OBSERVATION WAS AGAIN RECOMMENDED BY PATIENT'S SURGEON. (THE SURGEON CORRECTED ANATOMICAL NOMENCLATURE TO L5-S1 IN A SUBS

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 23571469 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A POSTERIOR FUSION (L2-ILIAC BONE) WAS PERFORMED ON (B)(6) 2021. AFTER THE SURGERY, AN ADJACENT SEGMENT DISEASE WAS CONFIRMED AND THE REMOVAL SURGERY AND PLIF (L1-2) WAS PERFORMED ON (B)(6) 2025. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A THIRTY (30) MINUTE DELAY. THE PATIENT STATUS WAS REPORTED AS STABLE. THIS REPORT CAPTURES THE FIRST PROCEDURE AND ITS CAUSE. THE REMOVAL PROCEDURE IS CAPTURED ON RELATED COMPLAINT: (B)(4).

  Patient problems: Osteolysis

  MAUDE report 23369522 ↗
• MalfunctionOct 15, 2025Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DRIVERS WERE STRIPPED FROM OVERUSE. THE SINGLE-INNER SETSCREW WON¿T STAY IN DRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23291156 ↗
• MalfunctionSep 17, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TIRF FOR AN ILIAC. DURING SURGERY, THE SI SET SCREW WAS STRIPPED, PREVENTING IT FROM TURNING AND PREVENTING THE APPLICATION OF TORQUE DURING FINAL TIGHTENING. THE SAI SCREW F8.0 X 80 MM HAD STRIPPED THREADS ON THE SCREW HEAD, CAUSING THE SET SCREW TO BE STRIPPED. THE PROBLEM WAS RESOLVED BY SWAPPING THE SCREW AND THE SET SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES OF DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23075057 ↗
• MalfunctionSep 17, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A TIRF FOR AN ILIAC ON (B)(6) 2025, THE SI SET SCREW WAS STRIPPED, PREVENTING IT FROM TURNING AND PREVENTING THE APPLICATION OF TORQUE DURING FINAL TIGHTENING. THE 8.0 X 80MM SAI SCREW HAD STRIPPED THREADS ON THE SCREW HEAD, CAUSING THE SET SCREW TO BE STRIPPED. THE PROBLEM WAS RESOLVED BY SWAPPING THE SCREW AND THE SET SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY (30) MINUTES OF SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23074762 ↗
• MalfunctionSep 17, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A TIRF FOR AN ILIAC ON (B)(6) 2025, THE SI SET SCREW WAS STRIPPED, PREVENTING IT FROM TURNING AND PREVENTING THE APPLICATION OF TORQUE DURING FINAL TIGHTENING. THE 8.0 X 80MM SAI SCREW HAD STRIPPED THREADS ON THE SCREW HEAD, CAUSING THE SET SCREW TO BE STRIPPED. THE PROBLEM WAS RESOLVED BY SWAPPING THE SCREW AND THE SET SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY (30) MINUTES OF SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23074761 ↗
• MalfunctionSep 17, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A TIRF FOR AN ILIAC ON (B)(6) 2025, THE SI SET SCREW WAS STRIPPED, PREVENTING IT FROM TURNING AND PREVENTING THE APPLICATION OF TORQUE DURING FINAL TIGHTENING. THE 8.0 X 80MM SAI SCREW HAD STRIPPED THREADS ON THE SCREW HEAD, CAUSING THE SET SCREW TO BE STRIPPED. THE PROBLEM WAS RESOLVED BY SWAPPING THE SCREW AND THE SET SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY (30) MINUTES OF SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23074760 ↗