SUMMIT 2570-03-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295143079), received between Jul 5, 2018 and Nov 5, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 5, 2025Break; Break

  IT WAS REPORTED THAT THE SUMMIT SZ2/3 STD NECK SEGMENT DEVICE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475685 ↗
• MalfunctionDec 18, 2023Off-Label Use; Device-Device Incompatibility; Material Integrity Problem; Off-Label Use; Device-Device Incompatibility; Material Integrity Problem

  ADDITIONAL INFORMATION WAS RECEIVED: A. CAN YOU PLEASE CLARIFY WHAT IS THE SPECIFIC DAMAGE OF THE REPORTED INSTRUMENT? WAS IT WORN, CRACKED, BROKEN INTO PIECES, BENT, STRIPPED, CROSS THREADED OR ANY DEVICE INTERACTION. 0 RING DAMAGED. TRIAL HEAD NOT SEATING. B. PLEASE CONFIRM THE QUANTITY OF THE DAMAGE SUMMIT SZ2/3 STD NECK SEGMENT?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18343709 ↗
• MalfunctionNov 10, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE WHITE PLASTIC HANDLE ARE CRACKED, THE STRIKE PLATE OF THE IMPACTOR IS BROKEN, THE RASP IS LOOSE WHEN SECURED ON IT, THE INNER PART IS DAMAGE PREVENTING THE NECK TO SIT PROPERLY, AND THE RING GRABS THE HEAD TRIALS TO TIGHT. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15777244 ↗
• MalfunctionJun 14, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THE NECK TRIAL AND THE SPACER GOT STUCK TOGETHER BECAUSE OF THE WEAR ON BOTH PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14685864 ↗
• MalfunctionMar 12, 2020Material Twisted/Bent; Material Twisted/Bent

  WORN ETCHINGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9822144 ↗
• MalfunctionMar 12, 2020Material Twisted/Bent; Material Twisted/Bent

  WORN ETCHINGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9822141 ↗
• MalfunctionJul 8, 2019Break; Break

  METAL RING CAME OFF SUMMIT NECK TRIAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8768928 ↗
• MalfunctionMar 22, 2019Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  DURING HIP SURGERY, DR (B)(6) NOTICED THAT THE TRIAL HEAD COULD NOT BE REMOVED FROM NECK SEGMENT WITH EASE. HE HAD TO USE HAMMER TO KNOCK IT OFF FROM THE SEGMENT. SEEMS THE SMALL METAL RING ON THE NECK SEGMENT IS DEFECTIVE. NO PATIENT HARM, NO DEBRIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8445583 ↗
• MalfunctionJul 5, 2018Material Discolored; Material Discolored

  PRODUCTS PRESENTED OXIDATION. IN THE EMAIL RECEIVED, CAME A LIST OF PRODUCTS SEPARATED BY BOX. THIS COMPLAINT REFERS TO THE PRODUCTS OF (B)(6) HOSPITAL IN BOX 2. PRODUCT: 257003050, LOT: MT40695. PRODUCT: 257003100, LOT: MT44718. PRODUCT: 257003150, LOT: MT47132. PRODUCT: 257003250, LOT: MT47299. PRODUCT: 257003350, LOT: MT45600. PRODUCT: 257003400, LOT: MT44738.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7663442 ↗