SUMMIT 2570-03-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295143086), received between Jul 5, 2018 and Nov 7, 2024 — 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 7, 2024Material Deformation; Naturally Worn; Illegible Information; Material Deformation; Naturally Worn; Illegible Information

  IT WAS REPORTED THAT THE DEVICE WAS VERY WORN. THERE WAS NO PATIENT IMPACT. SURGEON WAS ABLE TO FINISH THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20633378 ↗
• MalfunctionSep 16, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE RING ON NECK TRIAL IS DAMAGED AND NEEDS REPLACED. TRIAL HEAD WON¿T FIT ON.

  Patient problems: Insufficient Information

  MAUDE report 20224252 ↗
• MalfunctionJul 14, 2021Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT AS THE DOCTOR WAS PUTTING THE 2/3 HIGH OFFSET SUMMIT NECK TRIAL ON THE BROACH TO THE TRIAL, HE REALIZED THAT THE BOTTOM OF THE NECK TRIAL WAS DAMAGED SO THE NECK TRIAL WOULDN'T SIT CORRECTLY ON THE BROACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12170734 ↗
• MalfunctionJun 7, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TRIAL 28 +1.5 HEADBALL IS STUCK TO TRIAL SUMMIT NECK. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11945959 ↗
• MalfunctionMar 10, 2020Material Twisted/Bent; Material Twisted/Bent

  WORN ETCHINGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9815049 ↗
• MalfunctionMar 10, 2020Material Twisted/Bent; Material Twisted/Bent

  WORN ETCHINGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9815047 ↗
• MalfunctionMay 20, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  WHILE CLEANING UP AFTER A CEMENTED HIP HEMI ARTHROPLASTY IT WAS FOUND THAT CEMENT HAD MADE IT TO THE NECK TRIAL AND HAD HARDENED ON THE RETAINING RING. THE RING NOW DOES NOT MOVE AND I CAN¿T SAFELY REMOVE THE CEMENT AND THE NECK TRIAL IS NO LONGER USABLE FOR CASES. PATIENT STATUS/OUTCOME/CONSEQUENCES: NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8624937 ↗
• MalfunctionJul 5, 2018Corroded; Corroded

  THE MATERIALS PRESENTED OXIDATION. (B)(6). D257003150 NECK 2/3 HI LOT MT47132, D258003400 NECK 8/9 ST LOT MT447377, D2577003050 NECK 0/1 HI LOT MT40595, D267003200 NECK 4/5 ST LOT MT47047, D257003300 NECK ST 6/7 LOT MT47294, D24400549 STRAWBERRY 49 LOT S02019713, D24400542 STRAWBERRY 42 LOT S02015959.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7663579 ↗
• 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 7663445 ↗