PLIF 389.102Recalls & reported problems
Synthes GmbH · PLIF HOLDER · 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 10705034774541), received between Jun 1, 2018 and Nov 1, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 1, 2019Break; Break
IT WAS REPORTED THAT ON (B)(6) 2019, THE 90 DEGREE UP BITING LAMINECTOMY PUNCH WAS FOUND TO BE BROKEN AND POSTERIOR LUMBAR INTERBODY FUSION (PLIF) HOLDER WAS FOUND DUP LOT SCRAP DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) PLIF HOLDER. THIS IS 1 OF 1 FOR REPORT (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9268159 ↗MalfunctionSep 17, 2018Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE GRASPING END OF A POSTERIOR LUMBAR INTERBODY FUSION (PLIF) HOLDER HAD BROKEN. IT WAS UNKNOWN IF THERE WAS PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A PLIF HOLDER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7881705 ↗MalfunctionJun 1, 2018Break; Break
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE CENTRAL STERILE PROCESSING, THE HINGE WAS BROKEN ON THE COMPRESSION SPRING IN A POSTERIOR LUMBAR FUSION (PLIF) HOLDER. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A PLIF HOLDER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 7561778 ↗
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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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