SUMMIT 2570-03-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295143116), received between Jul 5, 2018 and Aug 20, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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.

• MalfunctionAug 20, 2024Break; Device-Device Incompatibility; Illegible Information; Break; Device-Device Incompatibility; Illegible Information

  IT WAS REPORTED THAT NECK TRIAL DOES NOT SIT FLUSH ON BROACH. CHIPPED AT BOTTOM. FADED AND UNABLE TO READ LETTERING. REQUESTED NEW ONE. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 20000856 ↗
• MalfunctionJul 2, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE NECK TRIAL DID NOT SEAT FLUSH ON 6 BROACH. BROACH NUB SEEMED NOT DAMAGED.

  Patient problems: Insufficient Information

  MAUDE report 19654209 ↗
• MalfunctionJun 12, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  NECK TRIAL LOCKING MECHANISM CAME OFF AND HEAD TRIAL NO LONGER LOCKS ON.

  Patient problems: Insufficient Information

  MAUDE report 19518664 ↗
• MalfunctionDec 19, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE NECK TRIAL NO LONGER ATTACHES TO BROACHES. NO PIECES WERE BROKEN OFF. NO SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16009467 ↗
• MalfunctionAug 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE LOCKING RING WAS MISSING FROM THE TRIAL NECK SEGMENT. NO DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12268170 ↗
• MalfunctionMar 12, 2020Material Twisted/Bent; Material Twisted/Bent

  WORN ETCHINGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9822151 ↗
• MalfunctionMar 12, 2020Material Twisted/Bent; Material Twisted/Bent

  WORN ETCHINGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9822148 ↗
• 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 7663626 ↗
• 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 7663420 ↗