MOUNTAINEER 188311012Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034156606), received between Jun 24, 2020 and Jun 22, 2026 — classified as 7 injuries, 1 malfunction.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020 IT WAS NOTED THAT SINCE SURGERY AND EXTUBATION, HER MENTAL STATUS HAS BEEN ALTERED. INITIALLY (B)(6) SHE 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), SHE 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 THE 2 PRIOR INTERVENTIONS AND EXTENDING DOWN INT

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

  MAUDE report 25585743 ↗
• InjuryAug 27, 2024Break; Break

  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) 2020 THE PATIENT WAS MORE LETHARGIC BUT BY DOCUMENTATION SEEMED TO HAVE A FLUCTUATING LEVEL OF AROUSAL/ALERTNESS AND SOME DISORIENTATION. STARTING (B)(6) 2020 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 THE 2 PR

  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 20077335 ↗
• MalfunctionMar 19, 2024Break; Break

  IT WAS REPORTED THAT SPINAL ROD BROKE FOUR YEARS POST-OP, PATIENT HAS MANUAL LABOR JOB (CONSTRUCTION) AND HEARD LOUD POP WHEN PICKING UP TOOL BAG, NO IMMEDIATE PAIN BUT FOLLOWED UP WITH CLINICIAN AND IT WAS FOUND THAT ROD HAD BROKEN. PATIENT IS FULLY HEALED, NO PAIN OR DISCOMFORT IN THE AREA, NO FRAGMENT GENERATION, ALL OTHER IMPLANTS (PEDICLE SCREWS) APPEAR TO BE IN TACT. THERE WAS POSTERIOR CERVICOTHORACIC FUSION, C6 TO T10. . INITIAL IMPLANTATION OCCURRED IN 2020. PATIENT HAD A CT SCAN LAST WEEK TO CONFIRM NO ADDITIONAL HARDWARE BREAKAGE, WHICH WAS CONFIRMED. ONLY THE SINGLE ROD FAILED. PATIENT HAS NO PAIN OR INDICATIONS FOR REMOVAL, THEREFORE THE IMPLANTS REMAIN IN THE PATIENT WITH NO ANTICIPATION OF REMOVAL. THERE WAS NO PATIENT OUTCOME. THIS REPORT IS FOR ONE (1) DUAL DIAMETER ROD 3.5X5.5, 600 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18928659 ↗
• InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT A CERVICAL-THORACIC POSTERIOR FUSION (C4-T2 EXCLUDING C7) FOR OSSIFICATION OF POSTERIOR LONGITUDINAL LIGAMENT (OPLL). ON (B)(6) 2021 THE PATIENT WAS DIAGNOSED WITH ADJACENT SEGMENT DISEASE (ASD) WHICH REQUIRED DECOMPRESSION FUSION BETWEEN T2 AND T3. ALL IMPLANTS FUSED IN 2011 HAD NO DEFECT SO THE FUSION WILL BE EXTENDED. THE REVISION OF C7, T3 (OR UP TO T4) WAS PLANNED FOR (B)(6) 2021. THIS REPORT IS FOR ONE (1) DUAL DIAMETER ROD 3.5X5.5, 600. THIS IS REPORT 2 OF 11 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 12814171 ↗
• InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT A CERVICAL-THORACIC POSTERIOR FUSION (C4-T2 EXCLUDING C7) FOR OSSIFICATION OF POSTERIOR LONGITUDINAL LIGAMENT (OPLL). ON (B)(6) 2021 THE PATIENT WAS DIAGNOSED WITH ADJACENT SEGMENT DISEASE (ASD) WHICH REQUIRED DECOMPRESSION FUSION BETWEEN T2 AND T3. ALL IMPLANTS FUSED IN 2011 HAD NO DEFECT SO THE FUSION WILL BE EXTENDED. THE REVISION OF C7, T3 (OR UP TO T4) WAS PLANNED FOR (B)(6) 2021. THIS REPORT IS FOR ONE (1) DUAL DIAMETER ROD 3.5 X 5.5, 600. THIS IS REPORT 1 OF 11 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 12814136 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING A REMOVAL SURGERY OF A SPINE CONSTRUCT DUE TO INFECTION ON (B)(6) 2020, THE SURGEON WAS PLACED THE PATIENT IN A BRACE DUE TO POOR BONE QUALITY AND TERMINAL CANCER. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020. IT WAS UNKNOWN IF THE REMOVAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) DUAL DIAMETER ROD 3.5X5.5, 600. THIS IS REPORT 4 OF 5 FOR (B)(4). RELATED PRODUCT COMPLAINTS: (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10192199 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING A REMOVAL SURGERY OF A SPINE CONSTRUCT DUE TO INFECTION ON (B)(6) 2020, THE SURGEON WAS PLACED THE PATIENT IN A BRACE DUE TO POOR BONE QUALITY AND TERMINAL CANCER. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020. IT WAS UNKNOWN IF THE REMOVAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) DUAL DIAMETER ROD 3.5X5.5, 600. THIS IS REPORT 5 OF 5 FOR (B)(4). RELATED PRODUCT COMPLAINTS: (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10192113 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING A REMOVAL SURGERY OF A SPINE CONSTRUCT DUE TO INFECTION ON (B)(6) 2020, THE SURGEON WAS PLACED THE PATIENT IN A BRACE DUE TO POOR BONE QUALITY AND TERMINAL CANCER. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020. IT WAS UNKNOWN IF THE REMOVAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) DUAL DIAMETER ROD 3.5X5.5, 600. THIS IS REPORT 6 OF 10 FOR (B)(4). RELATED PRODUCT COMPLAINTS: (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10190800 ↗