MOSS 279712500Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705034198958), received between Sep 18, 2020 and Sep 6, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. TWO MMSI ROD STABILIZERS WERE FOUND TO HAVE THE DISTAL TIP ENDS SPLAYED AND WERE SLIPPING WHEN FINAL TIGHTENING. THE DEVICES WERE FROM DIFFERENT SETS. OTHER SETS WERE OPENED FOR USE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR A MMSI ROD STABILIZER.

  Patient problems: Insufficient Information

  MAUDE report 20159337 ↗
• MalfunctionSep 6, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. TWO MMSI ROD STABILIZERS WERE FOUND TO HAVE THE DISTAL TIP ENDS SPLAYED AND WERE SLIPPING WHEN FINAL TIGHTENING. THE DEVICES WERE FROM DIFFERENT SETS. OTHER SETS WERE OPENED FOR USE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR A MMSI ROD STABILIZER.

  Patient problems: Insufficient Information

  MAUDE report 20159315 ↗
• MalfunctionApr 12, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE OLD ITEMS WERE WORN OUT OVER THE TIME DUE TO WEAR AND TEAR OR WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) MMSI ROD STABILIZER. THIS IS REPORT 6 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19101529 ↗
• MalfunctionApr 12, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE OLD ITEMS WERE WORN OUT OVER THE TIME DUE TO WEAR AND TEAR OR WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) MMSI ROD STABILIZER THIS IS REPORT 5 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19101525 ↗
• MalfunctionApr 12, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE OLD ITEMS WERE WORN OUT OVER THE TIME DUE TO WEAR AND TEAR OR WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) MMSI ROD STABILIZER. THIS IS REPORT 4 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19101523 ↗
• MalfunctionJul 19, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING A SPINAL FUSION PROCEDURE, (3) ROD STABILIZERS WERE WORN AT THE DISTAL TIP. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN TIGHTENER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR (1) MMSI ROD STABILIZER. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12190944 ↗
• MalfunctionJul 19, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A SPINAL FUSION PROCEDURE, THREE (3) ROD STABILIZERS WERE WORN AT THE DISTAL TIP. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN TIGHTENER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) MMSI ROD STABILIZER. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12190899 ↗
• MalfunctionJul 19, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING A SPINAL FUSION PROCEDURE, THREE (3) ROD STABILIZERS WERE WORN AT THE DISTAL TIP. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN TIGHTENER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) MMSI ROD STABILIZER. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12190629 ↗
• MalfunctionOct 23, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A SPINE FUSION PROCEDURE ON (B)(6) 2020, THE EXPEDIUM ROD STABILIZERS WERE DAMAGED/WORN AT THE DISTAL END TIP AND DID NOT WORK APPROPRIATELY DURING THE SURGERY. THIS ISSUE PREVENTED ADEQUATE COUNTER TORQUE FORCE IN PERFORMING THE FINAL TIGHTENING. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10727522 ↗
• MalfunctionOct 23, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A SPINE FUSION PROCEDURE ON (B)(6) 2020, THE EXPEDIUM ROD STABILIZERS WERE DAMAGED/WORN AT THE DISTAL END TIP AND DID NOT WORK APPROPRIATELY DURING THE SURGERY. THIS ISSUE PREVENTED ADEQUATE COUNTER TORQUE FORCE IN PERFORMING THE FINAL TIGHTENING. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10727494 ↗
• MalfunctionOct 23, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A SPINE FUSION PROCEDURE ON (B)(6) 2020, THE EXPEDIUM ROD STABILIZERS WERE DAMAGED AT THE DISTAL END TIP AND DID NOT WORK APPROPRIATELY DURING THE SURGERY. THIS ISSUE PREVENTED ADEQUATE COUNTER TORQUE FORCE IN PERFORMING THE FINAL TIGHTENING. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10727418 ↗
• MalfunctionSep 18, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2020 DURING A L3-PELVIS TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF),A ROD TO ROD CONNECTOR WAS UTILIZED TO RUN A SIDE BY SIDE ROD FROM THE PELVIC SCREWS TO THE MAIN CONSTRUCT. WHILE ATTEMPTING TO FINAL TIGHTEN THE CONNECTOR, THE THREADS ON THE TIP OF THE FINAL TIGHTENING SHAFT TWISTED, RENDERING IT UNUSABLE. THE SHAFT WAS CHANGED OUT FOR AN ALTERNATE THAT IS KEPT IN THE SAME SET AND THE SAME EXACT PROBLEM HAPPENED. A VIPER FINAL TIGHTENING SET WAS OPENED AND THERE WERE NO PROBLEMS USING THE FINAL TIGHTENING SHAFT AND TORQUE HANDLE FROM THIS SET. THE PROCEDURE WAS COMPLETED AS INDICATED. THERE WAS SURGICAL DELAY OF FIVE (5) MINUTES. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICES: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN) UNKNOWN ROD CONNECTOR (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN) UNKNOWN PELVIC SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN) UNKNOWN SETSCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UPDATED: THE ROD STABILIZER FELL APART. IT WAS NOTICED DURING TRIAGE THAT THE END CAP COMES UNDONE, IT IS SUPPOSED TO BE ATTACHED VIA ADHESIVE. THIS COMPLAINT IN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10555989 ↗