SUMMIT 2570-03-250Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295143109), received between Feb 21, 2018 and Jun 6, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2025Break; Break

  IT WAS REPORTED THAT THE CONNECTOR JUNCTION BROKE ON 4/5 HI TRIAL NECK SEGMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22157790 ↗
• MalfunctionSep 23, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE RING AROUND THE SUMMIT 6/7 HIGH NECK TRIAL AND THE 4/5 HIGH OFFSET NECK TRIAL HAD BENT SO THAT THE HEAD WAS NOT STAYING ON.

  Patient problems: Insufficient Information

  MAUDE report 20278441 ↗
• MalfunctionFeb 26, 2024Break; Break

  IT WAS REPORTED THAT THE LOCKING RING BROKE ON THE NECK TRIAL. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777149 ↗
• MalfunctionJun 12, 2023Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17105155 ↗
• MalfunctionFeb 21, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE SUMMIT NECK TRIAL SNAP RING WAS STRETCHED WHICH WAS PREVENTING THE HEAD TRIALS FROM LOCKING ONTO THE NECK TRIAL. WHEN TRYING TO REDUCE THE HIP, BIPOLAR HEAD TRIAL WOULD NOT SEAT PROPERLY ONTO THE NECK TRIAL. THERE WAS A SURGICAL DELAY OF 3 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 16409031 ↗
• MalfunctionJan 25, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE NECK TRIAL HAD A BENT CLIP AND THE HEADS DID NOT SNAP ON. IT WAS ALSO REPORTED THAT THE SCREWDRIVER HANDLE WOULD NOT RATCHET FOR. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13341828 ↗
• MalfunctionNov 23, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE LOCKING RING BROKE ON NECK, HEAD TRIAL WOULD NO LONGER SIT ON NECK AND NEEDS TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12860788 ↗
• MalfunctionMar 10, 2020Material Twisted/Bent; Material Twisted/Bent

  WORN ETCHINGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9815052 ↗
• MalfunctionMar 10, 2020Material Twisted/Bent; Material Twisted/Bent

  WORN ETCHINGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9815048 ↗
• 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) 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 7663450 ↗
• 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) IN BOX 1. (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 7663403 ↗
• MalfunctionFeb 21, 2018Break; Break

  RING BROKE OFF OF THE NECK COLLAR PLEASE REPLACE ON PO# (B)(4). PATIENT CONSEQUENCE? :NO IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7285087 ↗