MOUNTAINEER 288304000Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10705034221298), received between Aug 28, 2017 and Aug 11, 2023 — classified as 2 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (17 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 32 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionFeb 1, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6). REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021. DURING A PSF (POSTERIOR SPINAL FUSION) IN THE CERVICAL AND THORACIC AREA TREATING ADJACENT INTERVERTEBRAL DISORDER, AFTER THE INSERTION OF A SCREW, THE SCREWDRIVER WAS NOT ABLE TO BE DETACHED FROM THE SCREW. THE PROCEDURE WAS COMPLETED LESS THAN 30-MINUTE SURGICAL DELAY. THIS REPORT IS FOR ONE (1) MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL DRIVER. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11262681 ↗
• MalfunctionFeb 1, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING A PSF (POSTERIOR SPINAL FUSION) IN THE CERVICAL AND THORACIC AREA TREATING ADJACENT INTERVERTEBRAL DISORDER, AFTER THE INSERTION OF A SCREW (UNK, THE SCREWDRIVER WAS NOT ABLE TO BE DETACHED FROM THE SCREW. THE PROCEDURE WAS COMPLETED LESS THAN 30-MINUTE SURGICAL DELAY. THIS REPORT IS FOR ONE (1) MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL DRIVER. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11262276 ↗
• MalfunctionOct 23, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING THE INSPECTION OF THE MOUNTAINEER TRAYS AT THE HOSPITAL, THEIR POLY AXIAL SCREWDRIVERS WERE WORN OUT AND NEEDED TO BE REPLACED. THIS REPORT IS FOR ONE (1) MINI-POLYAXIAL SCREWDRIVER. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10726576 ↗
• MalfunctionOct 23, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING THE INSPECTION OF THE MOUNTAINEER TRAYS AT THE HOSPITAL, THEIR POLY AXIAL SCREWDRIVERS WERE WORN OUT AND NEEDED TO BE REPLACED. THIS REPORT IS FOR ONE (1) MINI POLYAXIAL SCREWDRIVER. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10726509 ↗
• MalfunctionOct 23, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING THE INSPECTION OF THE MOUNTAINEER TRAYS AT THE HOSPITAL, THEIR POLY-AXIAL SCREWDRIVERS WERE WORN OUT AND NEEDED TO BE REPLACED. THIS REPORT IS FOR ONE (1) MINI-POLYAXIAL SCREWDRIVER. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10726469 ↗
• MalfunctionOct 23, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING THE INSPECTION OF THE MOUNTAINEER TRAYS AT THE HOSPITAL, THEIR POLY-AXIAL SCREWDRIVERS WERE WORN OUT AND NEEDED TO BE REPLACED. THIS REPORT IS FOR ONE (1) MINI-POLYAXIAL SCREWDRIVER. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10726456 ↗
• MalfunctionOct 23, 2020Material Twisted/Bent; Material Twisted/Bent

  THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10726431 ↗
• MalfunctionOct 23, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING THE INSPECTION OF THE MOUNTAINEER TRAYS AT THE HOSPITAL, THEIR POLYAXIAL SCREWDRIVERS WERE WORN OUT AND NEEDED TO BE REPLACED. THIS REPORT IS FOR ONE (1) MINI-POLYAXIAL SCREWDRIVER. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10726381 ↗
• InjuryJun 19, 2020Break; Entrapment of Device; Break; Entrapment of Device

  CONCOMITANT DEVICES REPORTED: SCREWS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 10174070 ↗
• MalfunctionMay 12, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE THE SURGEON WAS ATTEMPTING TO BACK A SCREW OUT AND SCREWDRIVER TIP SHEARED OFF INTO HEAD OF SCREW. SURGICAL DELAY IS UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL DRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10048193 ↗
• InjuryMar 13, 2020Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING A POSTERIOR FUSION OF THE C2-T8 TREATING A DROPPED HEAD, THE TIP OF THE SCREWDRIVER BROKE OFF WHILE INSERTING THE IMPLANT. IT SEEMED THAT THE BONE HAD BECOME ROBUST DUE TO OSSIFICATION. WITHOUT REMOVING THE FRAGMENT, THE SURGEON WAS ABLE TO DEPLOY A ROD AND COMPLETED THE PROCEDURE WITHOUT SURGICAL DELAY. CONCOMITANT DEVICE: UNKNOWN SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE MINIPOLYAXIAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9828807 ↗