MOUNTAINEERRecalls & reported problems across all models
Depuy Spine, LLC · 5 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 40
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 5 models of MOUNTAINEER by Depuy Spine, LLC in the FDA's device registry (GUDID). Together they are named in 40 adverse event reports in the FDA's MAUDE database, received between Jun 23, 2017 and May 13, 2024 — classified as 3 injuries, 37 malfunctions.
The most frequently reported specific device problem is “Break” (18 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
Reports received per month, all models
Most reported MOUNTAINEER problems
Device problems
- Break18
- Material Twisted/Bent17
- Device-Device Incompatibility10
- Entrapment of Device2
- Adverse Event Without Identified Device or Use Problem1
- Material Deformation1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- No Consequences Or Impact To Patient16
- No Known Impact Or Consequence To Patient4
- Foreign Body In Patient3
- No Code Available2
- Hemorrhage/Blood Loss/Bleeding1
- Not Applicable1
MOUNTAINEER models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MOUNTAINEER 288304000SCREWDRIVER32 reports
- MOUNTAINEER 288301024BIT, DRILL4 reports
- MOUNTAINEER 288320110BIT, DRILL2 reports
- MOUNTAINEER 288303000GAUGE, DEPTH1 report
- MOUNTAINEER 288320108BIT, DRILL1 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.
InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT UNDERWENT A POSTERIOR FUSION OF OCCIPITAL AND CERVICAL VERTEBRAE (CERVICAL VERTEBRAE) ON (B)(6) 2024, WITH SYMPHONY-OC. IN THE SURGERY, THE DEPTH GAGE IN QUESTION WAS USED FOR OC SCREW INSERTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. ON (B)(6) 2024, CEREBELLAR HEMORRHAGE OCCURRED, AND REVISION SURGERY WAS PERFORMED IN THE NEUROSURGERY DEPARTMENT. NO IMPLANT WAS REMOVED. THE SURGEON'S OPINION WAS CONFIRMED WHICH AN ANTERIOR PERFORATION MAY HAVE OCCURRED BY THE DEPTH GAGE DURING THE SURGERY ON (B)(6) 2024. THE PATIENT IS CURRENTLY UNDER FOLLOW UP AND STABLE. THIS REPORT IS FOR A DEPTH GAGE W/BALLTIP PROBE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19305579 ↗MalfunctionAug 11, 2023Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2023, THE DRIVE WAS FOUND WITH A TWISTED AND UNUSABLE HEAD IN THE SET WHEN RESTOCKING IT POSTOPERATIVELY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL DRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17508582 ↗MalfunctionMar 16, 2023Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE DR. WAS DOING A REVISION C3-T11 POSTERIOR FUSION. THE PATIENT ALREADY HAD SUMMIT IN HIS CERVICAL SPIN AND WHILE TRYING TO REMOVE THE SCREWS THE SCREWDRIVER TIP ((B)(4)) TWISTED AND BURRED. THERE WAS ANOTHER DRIVE ON THE SET SO WE USED THAT ONE TO REMOVE THE REMAINING SCREWS. AT THE END OF THE PROCEDURE I TAGGED THE ITEM AND SPOKE WITH CSSD AND ASKED THEM TO DECONTAMINATE IT AND PUT ASIDE FOR ME TO COLLECT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT OUTCOME/ CONSEQUENCES. THIS REPORT IS FOR ONE (1) MINIPOLYAXIAL SCREWDRIVER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16553914 ↗MalfunctionJul 2, 2021Break; Break
IT WAS REPORTED THAT, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE SCREWDRIVER WAS MISSING A PIECE. THIS REPORT IS FOR ONE (1) MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL DRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12111930 ↗MalfunctionJul 1, 2021Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR SURGERY OF POSTERIOR CERVICAL FUSION AT C7. DURING THE SURGERY, THE SCREWDRIVER¿S TIP WAS BROKEN WHEN INSERTING THE SCREW. THE SCREW WAS REMOVED. THE SURGERY WAS COMPLETED WITH 30-MINUTES DELAY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED. UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN) . THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) MINIPOLYAXIAL SCREWDRIVER. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12100162 ↗MalfunctionJun 7, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THAT THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE SCREWDRIVERS ARE STRIPPING AND GETTING STUCK IN SCREWS. IT WAS NOTICED IN THE POLY SCREWS AND THE FINAL TIGHTENING TIME. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY WITHOUT DELAY. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. THIS COMPLAINT INVOLVES UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR (1) MINI POLYAXIAL SCREWDRIVER. THIS REPORT IS 4 OF 6 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11952596 ↗MalfunctionJun 7, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THAT THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE SCREWDRIVERS ARE STRIPPING AND GETTING STUCK IN SCREWS. IT WAS NOTICED IN THE POLY SCREWS AND THE FINAL TIGHTENING TIME. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY WITHOUT DELAY. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. THIS COMPLAINT INVOLVES UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR (1) MINI POLYAXIAL SCREWDRIVER. THIS REPORT IS 1 OF 6 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11952592 ↗MalfunctionJun 7, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THAT THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE SCREWDRIVERS ARE STRIPPING AND GETTING STUCK IN SCREWS. IT WAS NOTICED IN THE POLY SCREWS AND THE FINAL TIGHTENING TIME. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY WITHOUT DELAY. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. THIS COMPLAINT INVOLVES UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR (1) MINI POLYAXIAL SCREWDRIVER. THIS REPORT IS 3 OF 6 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11952590 ↗MalfunctionJun 7, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THAT THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE SCREWDRIVERS ARE STRIPPING AND GETTING STUCK IN SCREWS. IT WAS NOTICED IN THE POLY SCREWS AND THE FINAL TIGHTENING TIME. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY WITHOUT DELAY. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. THIS COMPLAINT INVOLVES UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR (1) MINI POLYAXIAL SCREWDRIVER. THIS REPORT IS 5 OF 6 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11952578 ↗MalfunctionJun 7, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THAT THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE SCREWDRIVERS ARE STRIPPING AND GETTING STUCK IN SCREWS. IT WAS NOTICED IN THE POLY SCREWS AND THE FINAL TIGHTENING TIME. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY WITHOUT DELAY. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. THIS COMPLAINT INVOLVES UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR (1) MINI POLYAXIAL SCREWDRIVER. THIS REPORT IS 2 OF 6 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11952576 ↗MalfunctionJun 7, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THAT THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE SCREWDRIVERS ARE STRIPPING AND GETTING STUCK IN SCREWS. IT WAS NOTICED IN THE POLY SCREWS AND THE FINAL TIGHTENING TIME. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY WITHOUT DELAY. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. THIS COMPLAINT INVOLVES UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR (1) MINI POLYAXIAL SCREWDRIVER. THIS REPORT IS 6 OF 6 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11952566 ↗MalfunctionFeb 26, 2021Material Twisted/Bent; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INSPECTION, TWO (2) SCREWDRIVERS WERE NOTED AS STRIPPED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL DRIVER. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11385313 ↗MalfunctionFeb 26, 2021Material Twisted/Bent; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INSPECTION, TWO (2) SCREWDRIVERS WERE NOTED AS STRIPPED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL DRIVER. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11385248 ↗MalfunctionFeb 10, 2021Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL EVENT INFORMATION: THIS COMPLAINT INVOLVES SIX (6) DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11308264 ↗MalfunctionFeb 10, 2021Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL EVENT INFORMATION: THIS COMPLAINT INVOLVES SIX (6) DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11308076 ↗
Other Depuy Spine, LLC products
All Depuy Spine, LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page