NA 698342573Recalls & reported problems
Depuy Spine, LLC · MODIFIED INSTRUMENT POLYDRIVER X25 · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034490663), received between Jun 12, 2023 and Jun 12, 2023 — classified as 3 malfunctions.
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 18, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED ON AN UNKNOWN DATE, THE PART NUMBERS IN THE PHOTOS ARE THE PRODUCTION REFERENCES BUT AT SOME POINT WERE MODIFIED TO WHAT CAN BE SEEN HERE IN THE DECK. THERE WERE 2 OF THE ¿¿ WITH TAB¿? ASSEMBLIES AND 1 OF THE ¿¿NO-TAB ASSEMBLY WAS REMOVED FROM A HOSPITAL UPON IDENTIFICATION. THIS REPORT IS FOR ONE (1)MOD VERSE X25 POLYDRIVER. THIS IS REPORT 11 OF 11 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17109955 ↗MalfunctionJun 12, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED ON AN UNKNOWN DATE, THE PART NUMBERS IN THE PHOTOS ARE THE PRODUCTION REFERENCES BUT AT SOME POINT WERE MODIFIED TO WHAT CAN BE SEEN HERE IN THE DECK. THERE WERE 2 OF THE ¿¿ WITH TAB¿? ASSEMBLIES AND 1 OF THE ¿¿NO-TAB ASSEMBLY WAS REMOVED FROM A HOSPITAL UPON IDENTIFICATION. THIS REPORT IS FOR ONE (1)MOD VERSE X25 POLYDRIVER THIS IS REPORT 10 OF 11 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17109923 ↗MalfunctionJun 12, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED ON AN UNKNOWN DATE, THE PART NUMBERS IN THE PHOTOS ARE THE PRODUCTION REFERENCES BUT AT SOME POINT WERE MODIFIED TO WHAT CAN BE SEEN HERE IN THE DECK. THERE WERE 2 OF THE ¿¿ WITH TAB¿? ASSEMBLIES AND 1 OF THE ¿¿NO-TAB ASSEMBLY WAS REMOVED FROM A HOSPITAL UPON IDENTIFICATION. THIS REPORT IS FOR ONE (1) MOD VERSE X25 POLYDRIVER THIS IS REPORT 9 OF 11 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17109895 ↗
Other DRIVER, PROSTHESIS devices
- ATTUNE 2544-01-005Depuy (Ireland) · DRIVER, PROSTHESIS1,383 reports
- EXPEDIUM VERSE 299704230Medos International Sàrl · DRIVER, PROSTHESIS875 reports
- NA 9200-10-029Depuy (Ireland) · DRIVER, PROSTHESIS745 reports
- MOSS 279712600Depuy Spine, LLC · DRIVER, PROSTHESIS706 reports
- NA 2598-07-440Depuy (Ireland) · DRIVER, PROSTHESIS665 reports
- NA 2598-07-570Depuy (Ireland) · DRIVER, PROSTHESIS505 reports
- VIPER 286745550Depuy Spine, LLC · DRIVER, PROSTHESIS263 reports
- SUMMIT 2570-05-100Depuy (Ireland) · DRIVER, PROSTHESIS225 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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