AVS 48350951Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327267914), received between Mar 2, 2018 and Nov 21, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618872 ↗
• MalfunctionSep 29, 2025Difficult to Remove; Mechanical Jam; Difficult to Remove; Mechanical Jam

  A COMPANY REPRESENTATIVE REPORTED THAT TWO AVS PL SPACER INSERTERS WERE DIFFICULT TO DISASSEMBLE FROM THEIR IMPLANTS INTRA-OPERATIVELY AND THAT THE DEVICES APPEARED TO BE CROSS-THREADED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE FIRST OF TWO INSERTERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23176176 ↗
• MalfunctionSep 29, 2025Difficult to Remove; Mechanical Jam; Difficult to Remove; Mechanical Jam

  A COMPANY REPRESENTATIVE REPORTED THAT TWO AVS PL SPACER INSERTERS WERE DIFFICULT TO DISASSEMBLE FROM THEIR IMPLANTS INTRA-OPERATIVELY AND THAT THE DEVICES APPEARED TO BE CROSS-THREADED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE SECOND OF TWO INSERTERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23176090 ↗
• MalfunctionJul 2, 2024Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF AN AVS PL INSERTER FRACTURED OFF INTRA-OPERATIVELY DURING CAGE INSERTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19661260 ↗
• MalfunctionMar 15, 2024Corroded; Fracture; Corroded; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT THE INNER SHAFT OF AN AVS SPACER STRAIGHT INSERTER FRACTURED INTRA-OPERATIVELY WHILE THE SURGEON WAS REMOVING THE CAGE TO REPOSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18913420 ↗
• MalfunctionOct 28, 2022Material Deformation; Material Deformation

  A COMPANY REPRESENTATIVE REPORTED THAT AN AVS PL SPACER STRAIGHT INSERTER BENT INTRA-OPERATIVELY. IT WAS FURTHER REPORTED VIA FOLLOW UP COMMUNICATION THAT THE INSERTER WAS USED AT A DIFFICULT ANGLE AND EXCESSIVE FORCE WAS APPLIED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT INSERTER WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15693709 ↗
• MalfunctionAug 3, 2022Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event

  IT WAS REPORTED THAT THE TIP OF AN AVS PL SPACER STRAIGHT INSERTER BROKE OFF INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15161129 ↗
• MalfunctionJun 30, 2022Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation

  A COMPANY REPRESENTATIVE REPORTED THAT AN AVS PL INSERTER BENT AT THE DISTAL TIP AND MIDDLE DURING INTRA-OPERATIVE IMPLANT PLACEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14875781 ↗
• MalfunctionMar 2, 2018Material Deformation; Break; Disconnection; Material Deformation

  IT WAS REPORTED THAT UPON STARTING RATCHETING THE INSTRUMENT WASN'T DISCONNECTING FROM THE IMPLANT AND BROKE. TIGHT SPACE WAS OBSERVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7311386 ↗