MOUNTAINEERRecalls & reported problems across all models

We found 51 models of MOUNTAINEER by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 254 adverse event reports in the FDA's MAUDE database, received between Aug 14, 2013 and Jun 22, 2026 — classified as 68 injuries, 186 malfunctions.

The most frequently reported specific device problem is “Break” (65 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported MOUNTAINEER problems

MOUNTAINEER models

51 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MOUNTAINEER 288306100

  SCREWDRIVER
  84 reports
• MOUNTAINEER 188362031

  ORTHOSIS, SPINAL PEDICLE FIXATION
  26 reports
• MOUNTAINEER 188341200

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  14 reports
• MOUNTAINEER 188342200

  Thoracolumbosacral pedicle screw system
  9 reports
• MOUNTAINEER 188362037

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  9 reports
• MOUNTAINEER 288314000

  DRIVER, PROSTHESIS
  9 reports
• MOUNTAINEER 188311012

  Orthosis, cervical pedicle screw spinal fixation
  8 reports
• MOUNTAINEER 188318312

  Orthosis, cervical pedicle screw spinal fixation
  7 reports
• MOUNTAINEER 188362025

  Thoracolumbosacral pedicle screw system
  6 reports
• MOUNTAINEER 188318314

  Orthosis, cervical pedicle screw spinal fixation
  5 reports
• MOUNTAINEER 188320332

  Orthosis, cervical pedicle screw spinal fixation
  5 reports
• MOUNTAINEER 188311202

  Orthosis, cervical pedicle screw spinal fixation
  4 reports
• MOUNTAINEER 188311302

  Orthosis, cervical pedicle screw spinal fixation
  4 reports
• MOUNTAINEER 188320328

  Orthosis, cervical pedicle screw spinal fixation
  4 reports
• MOUNTAINEER 188341100

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  4 reports
• MOUNTAINEER 288312000

  SCREWDRIVER
  4 reports
• MOUNTAINEER 188318414

  Orthosis, cervical pedicle screw spinal fixation
  3 reports
• MOUNTAINEER 188318416

  Orthosis, cervical pedicle screw spinal fixation
  3 reports
• MOUNTAINEER 188319326

  Orthosis, cervical pedicle screw spinal fixation
  3 reports
• MOUNTAINEER 188320330

  Orthosis, cervical pedicle screw spinal fixation
  3 reports
• MOUNTAINEER 188312003

  Orthosis, cervical pedicle screw spinal fixation
  2 reports
• MOUNTAINEER 188318318

  Orthosis, cervical pedicle screw spinal fixation
  2 reports
• MOUNTAINEER 188318322

  Orthosis, cervical pedicle screw spinal fixation
  2 reports
• MOUNTAINEER 188318328

  Orthosis, cervical pedicle screw spinal fixation
  2 reports
• MOUNTAINEER 188319430

  Orthosis, cervical pedicle screw spinal fixation
  2 reports
• MOUNTAINEER 188362045

  ORTHOSIS, SPINAL PEDICLE FIXATION
  2 reports
• MOUNTAINEER 188363200

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  2 reports
• MOUNTAINEER 288305300

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  2 reports
• MOUNTAINEER 288306000

  DRIVER, PROSTHESIS
  2 reports
• MOUNTAINEER 188311301

  Orthosis, cervical pedicle screw spinal fixation
  1 report
• MOUNTAINEER 188316060

  Orthosis, cervical pedicle screw spinal fixation
  1 report
• MOUNTAINEER 188316120

  Orthosis, cervical pedicle screw spinal fixation
  1 report
• MOUNTAINEER 188318316

  Orthosis, cervical pedicle screw spinal fixation
  1 report
• MOUNTAINEER 188318320

  Orthosis, cervical pedicle screw spinal fixation
  1 report
• MOUNTAINEER 188318324

  Orthosis, cervical pedicle screw spinal fixation
  1 report
• MOUNTAINEER 188318412

  Orthosis, cervical pedicle screw spinal fixation
  1 report
• MOUNTAINEER 188318424

  Orthosis, cervical pedicle screw spinal fixation
  1 report
• MOUNTAINEER 188319320

  Orthosis, cervical pedicle screw spinal fixation
  1 report
• MOUNTAINEER 188319328

  Orthosis, cervical pedicle screw spinal fixation
  1 report
• MOUNTAINEER 188319422

  Orthosis, cervical pedicle screw spinal fixation
  1 report
• MOUNTAINEER 188319424

  Orthosis, cervical pedicle screw spinal fixation
  1 report
• MOUNTAINEER 188319525

  Orthosis, cervical pedicle screw spinal fixation
  1 report
• MOUNTAINEER 188320320

  Orthosis, cervical pedicle screw spinal fixation
  1 report
• MOUNTAINEER 188320326

  Orthosis, cervical pedicle screw spinal fixation
  1 report
• MOUNTAINEER 188320336

  Orthosis, cervical pedicle screw spinal fixation
  1 report
• MOUNTAINEER 188362010

  ORTHOSIS, SPINAL PEDICLE FIXATION
  1 report
• MOUNTAINEER 188364150

  ORTHOSIS, SPINAL PEDICLE FIXATION
  1 report
• MOUNTAINEER 288305700

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report
• MOUNTAINEER 288307200

  DRIVER, PROSTHESIS
  1 report
• MOUNTAINEER 288310045

  TAP, BONE
  1 report
• MOUNTAINEER 188310012

  Orthosis, cervical pedicle screw spinal fixation
  1 report

Recent MOUNTAINEER adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 25487433 ↗
• InjuryJun 12, 2026Migration

  IT WAS REPORTED THROUGH LEGAL DOCUMENTATION, THE PATIENT SUSTAINED INJURIES DUE TO A CAR ACCIDENT ON (B)(6) 2020. SUBSEQUENTLY, ON MARCH 3, 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

  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 25487386 ↗
• 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 25487309 ↗
• MalfunctionMay 19, 2026Material Twisted/Bent

  IT WAS REPORTED THAT INSTRUMENTS WORN DUE TO USE. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25221528 ↗
• MalfunctionMay 19, 2026Material Twisted/Bent

  IT WAS REPORTED THAT INSTRUMENTS WORN DUE TO USE. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25221527 ↗
• MalfunctionMay 19, 2026Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE (RIGHT SIDE), THE PLATE WING TIPS WERE TOO BENT. THERE WAS NO REPORTED PATIENT OR USER HERM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25221379 ↗
• MalfunctionMay 19, 2026Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE (RIGHT SIDE), THE PLATE WING TIPS WERE TOO BENT. THERE WAS NO REPORTED PATIENT OR USER HERM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25221378 ↗
• MalfunctionMay 19, 2026Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE (RIGHT SIDE), THE PLATE WING TIPS WERE TOO BENT. THERE WAS NO REPORTED PATIENT OR USER HERM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25221373 ↗
• MalfunctionJan 8, 2026Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PRODUCT WAS WORN DUE TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24011930 ↗
• MalfunctionNov 13, 2025Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY, THE OCCIPITAL PLATE BROKE, ALL THE BROKEN PARTS WERE REMOVED, ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23548064 ↗
• MalfunctionAug 19, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT COMBINED NECK AND SPINAL FIXATION SURGERY ON (B)(6) 2025. DURING THE SURGERY, THE PLATE BROKE DURING SHAPING OF THE DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22842268 ↗
• MalfunctionJul 18, 2025Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY, THE OCCIPITAL PLATE WAS FRACTURED WHILE BENDING, REMOVED ALL THE BROKEN PARTS. 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 22541099 ↗
• MalfunctionMay 16, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT AT A JNJ FACILITY ON AN UNKNOWN DATE, SEVERAL INSTRUMENTS FAILED A TORQUE LIMITING TEST. THE DEVICES ARE OUT OF CALIBRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038815 ↗
• MalfunctionMay 16, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT AT A JNJ FACILITY ON AN UNKNOWN DATE, SEVERAL INSTRUMENTS FAILED A TORQUE LIMITING TEST. THE DEVICES ARE OUT OF CALIBRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038806 ↗

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