N/A 698344808Recalls & reported problems
Depuy Spine, LLC · MODIFIED INSTRUMENT DRILL GUIDE · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034574356), received between May 22, 2024 and May 22, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2024Break; Break
IT WAS REPORTED THAT ON APR 4, 2024, THERE WAS C3-5 ACDF WITH CODA IMPLANT SYSTEM. THE DRILL BIT WAS USED WITH A DOUBLE BARREL DTS GUIDE AND RUBS AGAINST THE DRILL BIT, SHEDDING SMALL METAL PIECES. THE PIECES WERE REMOVED WITH A SUCTION AND NO PATIENT EVENT AT THAT TIME. THE DOUBLE BARREL DTS GUIDES ARE BEING REMOVED FROM THE HOSPITAL. THE DESIGN OF THE GUIDES ALLOWS FLEXING WHILE THE DRILL WAS BEING USED, WHICH CAUSED SHEDDING FROM THE DRILL BIT. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) MODIFIED INSTRUMENT DRILL GUIDE. THIS IS REPORT 5 OF 8 FOR (B)(4). THIS COMPLAINT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19372619 ↗
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- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
- DJO SURGICAL 342-10-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall51 reports
- DJO SURGICAL 341-10-707Encore Medical, L.P. · Guide, Surgical, Instrument81 reports
- NA 03.010.404Synthes GmbH · Guide, surgical, instrument73 reports
- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
- DJO SURGICAL 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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