N/A 7480265Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00721902759246), received between Dec 20, 2019 and Dec 2, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2020Naturally Worn; Naturally Worn

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L4/5 FUSION DUE TO STENOSIS. IT WAS REPORTED THAT BENDERS WERE WORN OUT. THERE WERE NO PATIENT SYMPTOMS/ COMPLICATIONS AS A RESULT OF THE EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10933054 ↗
• MalfunctionDec 20, 2019Break; Break

  PRE-OP DIAGNOSIS: SCOLIOSIS IT WAS REPORTED THAT ON (B)(6) 2019, INTRA-OP, THE TIP OF BENDER BROKE OFF WHEN THE SURGEON WAS BENDING THE ROD. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9506103 ↗