MOUNTAINEER 188320328Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034158129), received between Mar 6, 2018 and Aug 25, 2020 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2020Break; Break

  UPDATED EVENT DESCRIPTION: CONCOMITANT DEVICE REPORTED: UNKNOWN SET SCREW (PART#: UNKNOWN, LOT NUMBER: 251612, QUANTITY:(B)(4). UNKNOWN SET SCREW (PART#: UNKNOWN, LOT NUMBER: 257361, QUANTITY:(B)(4). MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 X 3.5 X 18MM (PART#:188318318, LOT NUMBER: 214475, QUANTITY:(B)(4). MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 X 3.5 X 16MM (PART#:188318316, LOT NUMBER: 220105, QUANTITY:(B)(4). MOUNTAINEER OCT SPINAL SYSTEM ROD 3.5 X 60MM (PART#:188316060, LOT NUMBER: BDME3VJ, QUANTITY:(B)(4). THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10448546 ↗
• InjuryAug 25, 2020Break; Break

  UPDATED EVENT DESCRIPTION: CONCOMITANT DEVICE REPORTED: UNKNOWN SET SCREW (PART#: UNKNOWN, LOT NUMBER: 251612, QUANTITY: 5). UNKNOWN SET SCREW (PART#: UNKNOWN, LOT NUMBER: 257361, QUANTITY: 1. MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 X 3.5 X 18MM. (PART#:188318318, LOT NUMBER: 214475, QUANTITY: 2). MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 X 3.5 X 16MM. (PART#:188318316, LOT NUMBER: 220105, QUANTITY: 2). MOUNTAINEER OCT SPINAL SYSTEM ROD 3.5 X 60MM. (PART#:188316060, LOT NUMBER: BDME3VJ, QUANTITY: 2). THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10448485 ↗
• InjuryJun 27, 2018Break; Break

  ON (B)(6) 2014, THE CERVICAL POSTERIOR FIXATION SURGERY WAS PERFORMED BY USING THE MOUNTAINEER SYSTEM. ON (B)(6) 2018, IT WAS REPORTED THAT THE SCREW SHAFT (PART#: UNK) AT C1 HAD BEEN BROKEN. THE REOPERATION IS SCHEDULED ON (B)(6) 2018. FURTHER INFORMATION WILL SOON BE PROVIDED BY OUR SALES REP.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 7643034 ↗
• MalfunctionMar 6, 2018Torn Material; Torn Material

  IN A POSTERIOR CERVICAL C2-C4 FUSION (B)(6) ATTEMPTED TO FINAL TIGHTEN THE 188341200 TALL SET SCREW ON THE LONG SHANK SCREW 188320328 AND IT WOULD NOT TIGHTEN; JUST SPINNING AND NOT ENGAGING THE SCREW THREADS. MULTIPLE DIFFERENT 188341200 SET SCREWS WERE USED BUT NONE THREADED. IT WAS UNKNOWN BUT POSSIBLE THE TORQUE WAS OUT OF CALIBRATION AND DAMAGED THE SCREW. THE AFFECTED 188320328 SCREW AND SEVERAL OF ATTEMPTED TALL SET SCREWS WITH NUTS 188341100 AND 188341200 ARE BEING RETURNED FOR INVESTIGATION AS WELL AS ALL TORQUE DRIVERS TO ENSURE PATIENT SAFETY. THERE WAS ALSO A 188341028 CROSS CONNECTOR AT THIS LEVEL BUT WAS UNLIKELY TO HAVE CAUSED THE PROBLEM. THE SURGERY FINISHED WITHOUT FURTHER INCIDENT AFTER NEW TRAYS WERE OPENED AND A 188320328 SCREW WAS PLACED. REPLACEMENT P.O. FOR INSTRUMENTS (B)(4). PATIENT CONSEQUENCE? NO. PATIENT CONSEQUENCE DESCRIPTION: DELAY IN SURGERY TO ACQUIRE REPLACEMENT INSTRUMENTS AND IMPLANTS. ACTION TAKEN FOR PROCEDURE:NEW TRAYS OPENED IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7318324 ↗