SUMMIT 2570-03-400Recalls & reported problems
Depuy (Ireland) · SUMMIT NECK SEGMENT SIZE 8/9 STD · Class 1
All models of SUMMIT (43)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295143130), received between Jul 5, 2018 and Jan 21, 2022 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (2 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
Device problems
- Material Twisted/Bent2
- Corroded1
- Material Discolored1
- Naturally Worn1
Patient problems
- No Consequences Or Impact To Patient4
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 21, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE NECK TRIAL IS WORN AND THE HEAD TRIAL WILL NO LONGER CONNECT TO IT. THIS DID NOT OCCUR DURING SURGERY. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13315630 ↗MalfunctionMar 12, 2020Material Twisted/Bent; Material Twisted/Bent
MalfunctionMar 12, 2020Material Twisted/Bent; Material Twisted/Bent
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 7663597 ↗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 7663474 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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