Vitality® 07.02100.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024010338), received between Jul 13, 2021 and Nov 20, 2025 — classified as 9 malfunctions.

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

• MalfunctionNov 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE SCREW ON A VITALITY ROD GRIPPER BROKE DURING A SURGERY. THE PARTS WERE RETRIEVED BOTH INSIDE AND OUTSIDE THE SURGICAL FIELD. THERE WAS NO PATIENT HARM AND ONLY A 20 MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610713 ↗
• MalfunctionJan 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF A VITALITY ROD GRIPPER FRACTURED DURING A HARDWARE REMOVAL OF A ROD. THE TIP WAS RETRIEVED AND A DIFFERENT ROD GRIPPER WAS USED TO COMPLETE THE CASE WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18498421 ↗
• MalfunctionNov 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF A VITALITY ROD GRIPPER BROKE OFF WHILE REMOVING A PREVIOUSLY-IMPLANTED ROD INTRA-OPERATIVELY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18240067 ↗
• MalfunctionMar 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, WITH THE FORCE OF TRYING TO BEND THE ROD INTO THE SCREW HEAD AND WHILE HITTING ROD GRIPPER WITH A MALLET, THE TIP OF THE ROD GRIPPER FRACTURED. ANOTHER ROD GRIPPER WAS USED TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16485091 ↗
• MalfunctionAug 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PIVOT SCREW CLOSEST TO THE TIP OF TWO VITALITY ROD GRIPPERS BROKE INTRA-OPERATIVELY, MAKING THEM UNUSABLE. THE POLARIS GRIPPERS WERE USED TO COMPLETE THE SURGERY WITHOUT PATIENT IMPACTS. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15179090 ↗
• MalfunctionAug 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PIVOT SCREW CLOSEST TO THE TIP OF TWO VITALITY ROD GRIPPERS BROKE INTRA-OPERATIVELY, MAKING THEM UNUSABLE. THE POLARIS GRIPPERS WERE USED TO COMPLETE THE SURGERY WITHOUT PATIENT IMPACTS. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15179057 ↗
• MalfunctionJun 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT A VITALITY ROD GRIPPER BROKE DURING A CASE: THE MIDDLE SET SCREW FRACTURED. THERE WAS NO REPORTED PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14639144 ↗
• MalfunctionMar 3, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE CENTER SCREW OF A VITALITY ROD GRIPPER BROKE WHILE SURGEON WAS USING IT ON A ROD DURING POSTERIOR SPINAL FUSION. THERE WAS NO REPORTED PATIENT HARM AND ALL PIECES WERE ACCOUNTED FOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13663807 ↗
• MalfunctionJul 13, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF A ROD GRIPPER BROKE IN SURGERY; THE TIP WAS RETRIEVED AND THERE WERE NO PATIENT IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12158177 ↗