PLIF 394.571Recalls & reported problems
Synthes GmbH · PLIF GRAFT PUSHER · Class 1
Data updated Oct 16, 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 10705034777320), received between Apr 19, 2019 and Apr 24, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break2
- Material Integrity Problem1
Patient problems
- No Patient Involvement2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2026Material Integrity Problem
IT WAS REPORTED THAT THE HANDLE ON THE GRAFT PUSHER BROKE DURING SURGERY AND THEREFORE THE INSTRUMENT IS NO LONGER FUNCTIONAL. NO FRAGMENTS WERE GENERATED, THE HANDLE CRACKED AND CREATED A FISSURE. THERE WAS NO PATIENT HARM AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24987214 ↗MalfunctionApr 19, 2019Break; Break
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HANDLES OF THE TWO (2) POSTERIOR LUMBAR INTERBODY FUSION (PLIF) GRAPHIC PUSHER BROKE IN HALF. THIS WAS DISCOVERED WHILE IN THE WASH IN MEDICAL DEVICE REPROCESSING DEPARTMENT (MDRD). THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A PLIF GRAFT PUSHER. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 8531158 ↗MalfunctionApr 19, 2019Break; Break
DEVICE REPORT FROM (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HANDLES OF THE TWO (2) POSTERIOR LUMBAR INTERBODY FUSION (PLIF) GRAPHIC PUSHER BROKE IN HALF. THIS WAS DISCOVERED WHILE IN THE WASH IN MEDICAL DEVICE REPROCESSING DEPARTMENT (MDRD). THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A PLIF GRAFT PUSHER. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 8531131 ↗
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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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