SUMMIT 2570-03-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295143093), received between Jul 5, 2018 and Nov 4, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2025Break; Break

  IT WAS REPORTED THAT THE SURGEON COULD NOT TRIAL OFF THIS NECK TRIAL COMPONENT BECAUSE THE RING PIECE WAS BROKEN. IT WAS REPORTED THAT THE PROCEDURE WAS DELAYED FOR 5 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23465722 ↗
• MalfunctionJul 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TRIAL HEAD WOULD NOT STAY ON TRIAL NECK. NO SURGICAL DELAY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19721779 ↗
• MalfunctionJan 25, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE SUMMIT SIZE 4/5 STD NECK TRIAL IS NOT CLIPPING INTO THE HEAD TRIALS, THERE MUST BE DAMAGE TO THE RING AROUND THE NECK TRIAL. IT WAS UNKNOWN ABOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18582913 ↗
• MalfunctionJan 22, 2023Break; Break

  LOCKING RINGS ON TWO (2) 4/5 STD SUMMIT NECK TRIALS BROKE DURING SURGERY. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16221819 ↗
• MalfunctionJan 22, 2023Break; Break

  LOCKING RINGS ON TWO (2) 4/5 STD SUMMIT NECK TRIALS BROKE DURING SURGERY. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16221818 ↗
• MalfunctionJul 6, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BROACH HANDLE DIFFICULTY ATTACHING TO BROACH. NECK SEGMENT WAS DIFFICULT TO ASSEMBLE. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14934421 ↗
• MalfunctionMar 31, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DURING A THA THE SURGEON COMPLAINED THAT A SUMMIT 4/5 STANDARD NECK SEGMENT WAS NOT EFFECTIVELY HOLDING THE TRIAL BALL IN PLACE AND THE BALL WOULD EASILY BECOME DISSOCIATED FROM THE NECK SEGMENT. THERE WAS NO DELAY TO THE PROCEDURE; NO PATIENT CONSEQUENCES; PROCEDURE WAS COMPLETED AS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11598326 ↗
• MalfunctionNov 17, 2020Break; Detachment of Device or Device Component; Device-Device Incompatibility; Break; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT THE NECK TRIAL RING FELL OFF AND NO LONGER HOLDS HEAD TRIAL ON. 57 REAMER BASKET BROKE AT ATTACHMENT POINT. ALL PIECES REMOVED FROM PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10854908 ↗
• MalfunctionMar 12, 2020Material Twisted/Bent; Material Twisted/Bent

  WORN ETCHINGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9822143 ↗
• MalfunctionMar 12, 2020Material Twisted/Bent; Material Twisted/Bent

  WORN ETCHINGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9822140 ↗
• MalfunctionJan 24, 2019Material Twisted/Bent; Material Twisted/Bent

  THE U-RING ON 4/5 STD NECK WAS BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8273726 ↗
• 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 7663618 ↗
• 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. (B)(6). PRODUCT: 257003050, LOT: MT40595; PRODUCT: 257003250, LOT: MT47299; PRODUCT: 257003350, LOT: MT45800; PRODUCT: 257003200, LOT: MT47074; PRODUCT: 257003300, LOT: MT47294.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7663415 ↗