IPS 60-000-65-09-LPRecalls & reported problems
KLS-Martin L.P. · IMPLANT, MANDIBLE, 00065, LP, TI-6AL-4V · Class 2 · Implant
All models of IPS (29)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888118140364), received between Aug 15, 2024 and Aug 15, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration2
Patient problems
- Inadequate Osseointegration2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 15, 2024Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PORTION OF AN IPS PLATE OVER A GRAFT JUNCTION FRACTURED THREE MONTHS AFTER IMPLANT DUE TO LOSS OF OSSEOINTEGRATION AT THE JUNCTION. IT WAS REMOVED AND THE REST OF THE PLATE REMAINS IMPLANTED.
Patient problems: Inadequate Osseointegration
MAUDE report 19996231 ↗InjuryAug 15, 2024Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PORTION OF AN IPS PLATE OVER A GRAFT JUNCTION FRACTURED THREE MONTHS AFTER IMPLANT DUE TO LOSS OF OSSEOINTEGRATION AT THE JUNCTION. IT WAS REMOVED AND THE REST OF THE PLATE REMAINS IMPLANTED.
Patient problems: Inadequate Osseointegration
MAUDE report 19996230 ↗
Other DRIVER, WIRE, AND BONE DRILL, MANUAL devices
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- NA 5400007000Stryker Corporation · DRIVER, WIRE, AND BONE DRILL, MANUAL20 reports
- VSP System Mandible Cutting Guide3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual13 reports
- VSP System Intermediate Surgical Splint3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual6 reports
- VSP System Fibula Cutting Guide with Implant Placement3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual6 reports
- NA 03.505.007Synthes GmbH · DRIVER, WIRE, AND BONE DRILL, MANUAL6 reports
- VSP System Fibula Cutting Guide3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual5 reports
- NA 03.505.041Synthes GmbH · DRIVER, WIRE, AND BONE DRILL, MANUAL4 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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