SUMMIT 2570-00-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295142874), received between Mar 22, 2021 and Nov 15, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Illegible Information” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2023Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT THE CONNECTION TO BROACH HANDLE WAS DAMAGED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144732 ↗
• MalfunctionMar 22, 2021Material Twisted/Bent; Illegible Information; Material Twisted/Bent; Illegible Information

  IT WAS REPORTED THAT THE BROACHES WERE WORN FROM NORMAL USE THEY WERE NOT REMOVING ENOUGH BONE THEN CAUSING THE IMPLANT TO SIT PROUD A BIT. SURGERY WASN¿T DELAYED AND NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11541679 ↗
• MalfunctionMar 22, 2021Material Twisted/Bent; Illegible Information; Material Twisted/Bent; Illegible Information

  IT WAS REPORTED THAT THE BROACHES WERE WORN FROM NORMAL USE THEY WERE NOT REMOVING ENOUGH BONE THEN CAUSING THE IMPLANT TO SIT PROUD A BIT. SURGERY WASN¿T DELAYED AND NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11541592 ↗