IPS 60-000-67-09-LPRecalls & reported problems
KLS-Martin L.P. · IMPLANT, MAND/ORTHOG, 00067, 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
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888118140388), received between Sep 4, 2024 and Jun 24, 2026 — classified as 8 injuries.
The most frequently reported specific device problem is “Break” (4 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
- Adverse Event Without Identified Device or Use Problem4
- Break4
- Failure to Osseointegrate2
Patient problems
- Insufficient Information4
- Inadequate Osseointegration2
- Nonunion/Delayed-union Bone Fracture2
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN IPS IMPLANT WAS REMOVED FOLLOWING APPROXIMATELY SEVEN MONTHS OF IMPLANTATION.
Patient problems: Insufficient Information
MAUDE report 25610341 ↗InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT RT. SIDE MANDIBULAR HARDWARE WAS REMOVED FOR UNKNOWN REASONS 14 WEEKS AFTER IMPLANTATION. THERE WERE NO REPORTED ISSUES WITH THE REMOVED PRODUCT.
Patient problems: Insufficient Information
MAUDE report 25176991 ↗InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem
AN IPS IMPLANT WAS REMOVED SIX MONTHS AFTER IMPLANT FOR UNKNOWN REASONS. SURGEON ADVISED NO HARDWARE ISSUES WITH PRODUCT.
Patient problems: Insufficient Information
MAUDE report 24771350 ↗InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem
AN IPS IMPLANT WAS REMOVED SIX MONTHS AFTER IMPLANT FOR UNKNOWN REASONS. SURGEON ADVISED NO HARDWARE ISSUES WITH PRODUCT.
Patient problems: Insufficient Information
MAUDE report 24771339 ↗InjurySep 10, 2024Break; Break
IT WAS REPORTED A MANDIBLE PLATE BROKE 10 WEEKS AFTER IMPLANT SECONDARY TO A NON-UNION WITH PATIENT INVOLVEMENT. IT WAS REMOVED AND REPLACED.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 20186013 ↗InjurySep 10, 2024Break; Break
IT WAS REPORTED A MANDIBLE PLATE BROKE 10 WEEKS AFTER IMPLANT SECONDARY TO A NON-UNION WITH PATIENT INVOLVEMENT. IT WAS REMOVED AND REPLACED.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 20186012 ↗InjurySep 4, 2024Break; Failure to Osseointegrate; Break; Failure to Osseointegrate
IT WAS REPORTED THAT A MANDIBULAR PLATE SEPARATED 3+ MONTHS AFTER IMPLANT, LIKELY DUE TO PATIENT NON-COMPLIANCE WITH POST-OP INSTRUCTIONS. IT WAS REMOVED AND REPLACED.
Patient problems: Inadequate Osseointegration
MAUDE report 20140633 ↗InjurySep 4, 2024Break; Failure to Osseointegrate; Break; Failure to Osseointegrate
IT WAS REPORTED THAT A MANDIBULAR PLATE SEPARATED 3+ MONTHS AFTER IMPLANT, LIKELY DUE TO PATIENT NON-COMPLIANCE WITH POST-OP INSTRUCTIONS. IT WAS REMOVED AND REPLACED.
Patient problems: Inadequate Osseointegration
MAUDE report 20140632 ↗
Other PLATE, BONE devices
- MatrixNEURO 04.503.104.01Synthes GmbH · PLATE, BONE252 reports
- RapidSorb 806.004.02SSynthes GmbH · PLATE, BONE146 reports
- TruMatch SD980.001Materialise NV · Plate, Bone1 recall21 reports
- Matrix 04.511.225.01Synthes GmbH · PLATE, BONE62 reports
- NA 400.834Synthes GmbH · PLATE, BONE58 reports
- TruMatch SD980.016Materialise NV · Plate, Bone55 reports
- ProPlan CMF SD900.101Materialise NV · Plate, Bone1 recall1 report
- TruMatch SD980.013Materialise NV · Plate, Bone1 recall0 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.
How reports and recalls are matched · Editorial policy · Report an error on this page