MOUNTAINEER 188362031Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10705034158877), received between Feb 13, 2018 and Nov 13, 2025 — classified as 5 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJan 10, 2025Break; Break

  IT WAS REPORTED THAT DURING A SPINAL FUSION (OCCIPITAL BONE) FOR CSM, WHEN THE PLATE WAS BENT AT THE CRANIAL PART OF IT TO ADJUST FOR THE PATIENT, THE PLATE BROKE OFF. ANOTHER IMPLANT WAS USED AS THE PLATE BECAME UNUSABLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21129619 ↗
• MalfunctionJul 25, 2024Break; Break

  IT WAS REPORTED THAT THE MNTR OC PLATE SMALL BROKE DURING THE SURGERY ON (B)(6) 2024. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) MNTR OC PLATE SMALL THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19832447 ↗
• MalfunctionDec 4, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING THE SURGERY THE PLATE BROKE OFF. THERE WAS NO PROBLEM WITH THE USAGE. A SPARE PRODUCT WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES SURGICAL DELAY. THE PATIENT WAS REPORTED AS STABLE. THIS REPORT INVOLVES ONE (1) MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL PLATE 3.5 31MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18257692 ↗
• MalfunctionOct 1, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS A SPINAL FUSION (O-C3) PERFORMED ON (B)(6) 2022. THE SURGEON TRIED TO BEND THE PLATE IN QUESTION WITH THE PLATE BLENDER TO FIT THE PATIENT. THEN, THE CENTRAL PLATE BROKE OFF. THERE WAS A DELAY OF LESS THAN 30 MINUTES DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A NEW BENT PLATE. PATIENT STATUS/ OUTCOME: STABLE. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNK - BENDING INSTRUMENTS: PLATE BENDER. THIS REPORT IS FOR ONE (1) MNTR OC PLATE SMALL. THIS IS REPORT 1 OF 1 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15525188 ↗
• InjurySep 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A POSTERIOR CERVICAL FUSION (O-C3) PERFORMED ON (B)(6) 2022. THE SYMPHONY WAS USED FOR THE CERVICAL SPINE. THE MOUNTAINEER OCCIPITAL PLATE WAS USED FOR THE OCCIPITAL BONE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE SURGEON REPORTED THAT THE PATIENT WAS INFECTED ON (B)(6) 2022. THE REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2022. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) MNTR OC PLATE SMALL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15475559 ↗
• MalfunctionSep 8, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2022. THE SURGEON TRIED TO BEND THE PLATE IN QUESTION WITH THE PLATE BENDER WITH GENTLE FORCE. THEN, THE PLATE BROKE OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NEW BENT PLATE. THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN; LOT# UNKNOWN). THIS REPORT IS FOR ONE (1) MNTR OC PLATE SMALL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15379116 ↗
• InjuryMar 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY OF A POSTERIOR SPINAL FUSION ON (B)(6) 2022. THE ORIGINAL PROCEDURE WAS DONE ON (B)(6) 2022. ON AN UNKNOWN DATE FOLLOWING THE INITIAL PROCEDURE, THE MOUNTAINEER OC PLATE, TWO (2) RODS, AND TWO (2) SET SCREWS POPPED OUT. BOTH RODS POPPED OUT BUT WERE STILL IN THE CERVICAL PORTION. IT WAS NOTED THAT THE PATIENT DID NOT WEAR A NECK BRACE ALL THE TIME AND THE NECK MAY HAVE BEEN HYPEREXTENDED IN THE ORIGINAL CASE. THE DOCTOR HAD ONLY PUT TWO SCREWS ON THE PLATE. THE ANGLE WAS BAD, AND THE THIRD SCREW COULD NOT BE ADDED. PATIENT WAS REVISED TO AN OCCIPITAL TO T2 FUSION. IN THE REVISION, THE SURGEON PUT IN ALL THREE SCREWS. THIS REPORT IS FOR A MOUNTAINEER OCCIPITAL PLATE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13711814 ↗
• MalfunctionOct 5, 2021Break; Break

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A PCF (OC-C5) FOR TREATING CERVICAL SUBLUXATION DUE TO DISH ON (B)(6) 2021. THE SURGEON TRIED TO BEND THE PLATE WITH THE PLATE BENDER WITH GENTLE FORCE. THE PLATE BROKE, AND THE FRAGMENT GOT STUCK IN THE PLATE BENDER. THE PROCEDURE WAS COMPLETED WITH REPLACEMENTS AND A LESS THAN THIRTY (30) MINUTE SURGICAL DELAY. THE PATIENT OUTCOME WAS REPORTED AS STABLE. THIS REPORT IS FOR A MOUNTAINEER OCCIPITAL PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12577639 ↗
• InjurySep 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT FOR A REVISION SURGERY DUE TO SCREW FAILURE. IT WAS UNKNOWN IF THE REVISION SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THE PATIENT HAD A NECK REPAIR FOR A C2 FRACTURE IN AN UNKNOWN DATE OF (B)(6) 2021. THIS COMPLAINT INVOLVES UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR (1) MNTR OC SCREW 4.5X10. THIS REPORT IS 3 OF 4 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12428503 ↗
• MalfunctionJun 9, 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 THE SURGERY FOR FUSION PROCEDURE BETWEEN O-C2 TREATING CERVICAL MYELOPATHY. DURING THE SURGERY, THE PLATE IS BREAK-OFF. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN BENDER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) MNTR OC PLATE SMALL. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11969606 ↗
• MalfunctionDec 30, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE THE SURGEON COULD NOT FINALLY TIGHTEN THE LATERAL MASS SCREW USING THE X15 TORQUE DRIVER. UPON OPENING A SECOND BACKUP SET THAT HAD ANOTHER X15 TORQUE DRIVER, THE SCREW WAS ABLE TO ACHIEVE FINAL TIGHTENING AND TORQUED OUT. THE TWO MOUNTAINEER OC PLATES BROKE IN THE CASE AS WELL AS THE FINAL TIGHTENER. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED AND REMOVED. PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES THREE (3) DEVICE. THIS REPORT IS FOR (1) MNTR OC PLATE SMALL. THIS REPORT IS 2 OF 3 FOR PC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11097424 ↗
• MalfunctionDec 30, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE THE SURGEON COULD NOT FINALLY TIGHTEN THE LATERAL MASS SCREW USING THE X15 TORQUE DRIVER. UPON OPENING A SECOND BACKUP SET THAT HAD ANOTHER X15 TORQUE DRIVER, THE SCREW WAS ABLE TO ACHIEVE FINAL TIGHTENING AND TORQUED OUT. THE TWO MOUNTAINEER OC PLATES BROKE IN THE CASE AS WELL AS THE FINAL TIGHTENER. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED AND REMOVED. PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES THREE (3) DEVICE. THIS REPORT IS FOR (1) MNTR OC PLATE SMALL. THIS REPORT IS 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11097358 ↗
• MalfunctionDec 30, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE UPON ATTEMPTING TO CONTOUR THE TOP TABS OF THE OC PLATE, THE SURGEONS ASSISTANT SEVERED THE TOP TAB COMPLETELY OFF ON THREE SEPARATE PLATES. ALL THREE PLATES APPEARED TO BREAK AT THE BEND ZONE, TWO WERE REMOVED FROM THE FIELD AND SENT TO BE CLEANED, ONE REMAINS IN THE PATIENT UNDER THE SURGEONS CLINICAL DECISION TO USE IT. FRAGMENTS WERE GENERATED AND EASILY REMOVED. SURGEON ADVISED NOT TO USE THE COMPROMISED PLATES, ALSO REMINDED OF THE ON LABEL INDICATIONS. THE PLATE BROKE AS IT WAS BEING BENT ON THE MAYO STAND AND THE FRAGMENT THAT BROKE OFF WAS REMOVED. THERE WAS A SURGICAL DELAY OF UNKNOWN MINUTES. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL PLATE 3.5 31MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11096683 ↗
• MalfunctionDec 30, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE UPON ATTEMPTING TO CONTOUR THE TOP TABS OF THE OC PLATE, THE SURGEONS ASSISTANT SEVERED THE TOP TAB COMPLETELY OFF ON THREE SEPARATE PLATES. ALL THREE PLATES APPEARED TO BRAKE AT THE BEND ZONE, TWO WERE REMOVED FROM THE FIELD AND SENT TO BE CLEANED, ONE REMAINS IN THE PATIENT UNDER THE SURGEONS CLINICAL DECISION TO USE IT. FRAGMENTS WERE GENERATED AND EASILY REMOVED. SURGEON ADVISED NOT TO USE THE COMPROMISED PLATES, ALSO REMINDED OF THE ON LABEL INDICATIONS. THE PLATE BROKE AS IT WAS BEING BENT ON THE MAYO STAND AND THE FRAGMENT THAT BROKE OFF WAS REMOVED. THERE WAS A SURGICAL DELAY OF UNKNOWN MINUTES. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL PLATE 3.5 31MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11096620 ↗
• MalfunctionDec 30, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE UPON ATTEMPTING TO CONTOUR THE TOP TABS OF THE OC PLATE, THE SURGEONS ASSISTANT SEVERED THE TOP TAB COMPLETELY OFF ON THREE SEPARATE PLATES. ALL THREE PLATES APPEARED TO BRAKE AT THE BEND ZONE, TWO WERE REMOVED FROM THE FIELD AND SENT TO BE CLEANED, ONE REMAINS IN THE PATIENT UNDER THE SURGEONS CLINICAL DECISION TO USE IT. FRAGMENTS WERE GENERATED AND EASILY REMOVED. SURGEON ADVISED NOT TO USE THE COMPROMISED PLATES, ALSO REMINDED OF THE ON LABEL INDICATIONS. THE PLATE BROKE AS IT WAS BEING BENT ON THE MAYO STAND AND THE FRAGMENT THAT BROKE OFF WAS REMOVED. THERE WAS A SURGICAL DELAY OF UNKNOWN MINUTES. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL PLATE 3.5 31MM. THIS IS REPORT 2 OF 3 FOR (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11096596 ↗
• MalfunctionDec 17, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING AND UNKNOWN PROCEDURE THAT THE PLATE BROKE PREMATURELY DURING BREAKING. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL. THERE WAS NO CONSEQUENCE TO THE PATIENT. THIS REPORT INVOLVES ONE (1) MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL PLATE 3.5 31MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11030699 ↗
• MalfunctionSep 29, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING SPINAL FUSION PROCEDURE, THE SURGEON TRIED TO BEND THE PLATE GRADUALLY WITH A BENDER AS PER THE SURGICAL INSTRUCTION. THE SALES REP ADVISED THE SURGEON NOT TO BEND THE PLATE OVER 15 DEGREES, BUT THE PLATE BROKE OFF. THERE WAS NO SURGICAL DELAY. PATIENT STATUS IS STABLE. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: BENDER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) MNTR OC PLATE SMALL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10603320 ↗
• InjuryJun 19, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, A REVISION WAS DONE ON A PATIENT WITH BROKEN MOUNTAINEER OC PLATE. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNKNOWN RODS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL PLATE 3.5 31 MM THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10176437 ↗
• MalfunctionMar 31, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, A SPINAL FUSION PROCEDURE TREATING RHEUMATISM WAS PERFORMED. IN ORDER TO SHAPE THE PLATE TO THE CONTOUR OF THE OCCIPITAL BONE, THE SURGEON BENT THE PLATE GRADUALLY. THEN ITS DISTAL SIDE BROKE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL PLATE 3.5 31MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9903924 ↗
• MalfunctionFeb 7, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED, ON (B)(6) 2020, OF A POSTERIOR SPINAL FUSION SURGERY TREATING SPINAL NEOPLASM. WHILE THE PLATE (188362031) WAS BEING SLOWLY BENT INTRAOPERATIVELY, IT BROKE OFF. THE PROCEDURE WAS COMPLETED LESS THAN 30-MINUTE SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9682663 ↗
• MalfunctionOct 7, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  DURING OCCIPIT TO C4 FUSION WITH MOUNTAINEER, SURGEON ATTEMPTED TO FINAL TIGHTEN RIGHT SIDE OCCIPITAL SET SCREW (188362025) ON THE OCCIPITAL PLATE (188362031) AND FELT THE FINAL TIGHTENER (288314000) STRIPPING THE SET SCREW. A COUNTERTORQUE AND ROD HOLDER WERE USED AT THE TIME OF FINAL TIGHTENING FOR STABILIZATION. HE COULD NOT GET ANOTHER OC SET SCREW TO ENGAGE WITH THE PLATE AGAIN, AND BELIEVED THE ROD CAPTURING HEAD ON THE PLATE WAS BROKEN, OR SPLAYED. THE SET SCREW THAT STRIPPED WAS INADVERTENTLY DISCARDED. THE SURGEON HAD TO REMOVE ALL SET SCREWS AND THE RODS IN ORDER TO ACCESS THE PLATE TO REMOVE IT. IT WAS REPLACED WITH THE SAME SIZE AND ANOTHER TRAY WAS OPENED FOR A SECOND FINAL TIGHTENER. IT IS SUSPECTED THIS WAS CAUSED BY AN OUT-OF-CALIBRATION FINAL TIGHTENER. I AM ALSO REQUESTING EXCHANGES FOR ALL MOUNTAINEER FINAL TIGHTENERS IN AN ABUNDANCE OF CAUTION.

  Patient problems: Not Applicable

  MAUDE report 9163101 ↗
• MalfunctionFeb 26, 2018Break; Break

  OC PLATES BROKE WHILE BENDING. OC PLATE ROD CAPTURE WAS SPLAYED AND COULD NOT LOCK A SET SCREW ADDITIONAL INFORMATION RECEIVED FROM REP: THE FIRST PLATE HAD THE ISSUE WITH THE SPLAYING OF THE RIGHT ROD CAPTURE (TULIP HEAD). THE 2ND AND 3RD PLATES WERE THEN BROKEN WHEN TRYING TO CONTOUR BECAUSE WE HAD TO REMOVE THE FIRST PLATE. SURGEON COMPLETED THE CASE, THE EVENT PROBABLY DELAYED THE CASE ABOUT 30 MINUTES. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: No Known Impact Or Consequence To Patient; Not Applicable

  MAUDE report 7297321 ↗