NA 329.30Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982191953), received between Dec 19, 2018 and Sep 18, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT THE PLATE BENDER WAS STUCK. NO DELAYED DUE TO THE REPORTED EVENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23082553 ↗
• MalfunctionMay 2, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2025, THE U ARM WAS BENT AT THE END OF THE BOLT PLATE AND WAS NOT LOCKING. THE ISSUE WAS OBSERVED DURING ASSEMBLY. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21952766 ↗
• MalfunctionFeb 22, 2023Mechanical Problem; Device-Device Incompatibility; Mechanical Problem; Device-Device Incompatibility

  AFTER INSPECTING THE TABLE TOP PLATE BENDER, IT WAS NOTICED THAT THE TOP PART OF LOWER ANVIL ADJUSTMENT SCREW WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16418122 ↗
• MalfunctionFeb 9, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DEVICE BENDING PRESS, LENGTH 400 MM DOES NOT MOVE AT ALL, PLATE GOES IN AND DOES NOT ADJUST. IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED. IT IS UNKNOWN IF THERE IS PATIENT INVOLVEMENT. IT IS UNKNOWN IF REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION OCCURRED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) PLATE-BENDING PRESS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16336712 ↗
• MalfunctionMar 30, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT THE BENDING INSTRUMENTATION IS NOT RECOILING AND NEEDS TO BE MANUALLY PUSHED BACK IN TO RESET. THIS WAS CAUGHT WHEN INSPECTING THE INSTRUMENT AND WORKED FINE DURING SURGERY. NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE PLATE-BENDING PRESS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13952689 ↗
• MalfunctionMar 10, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PLATE BENDING PRESS DID NOT PRESS. THE ISSUE WAS FOUND DURING ROUTINE INSPECTION. THERE IS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) PLATE-BENDING PRESS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9812063 ↗
• MalfunctionDec 19, 2018Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PLATE-BENDING PRESS HAD AN UNSPECIFIED MALFUNCTION. IT WAS NOTED DURING INSPECTION DELIVERY THAT THE SET SCREW WILL NOT TIGHTEN FOR PLATE AND ON THE SIDE LEVEL. THERE IS NO PATIENT OR PROCEDURE INVOLVEMENT. CONCOMITANT DEVICES: TRAUMA PLATE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A PLATE-BENDING PRESS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8179202 ↗