IPS 60-650-01-04Recalls & reported problems
KLS-Martin L.P. · PLATE, MANDIBLE, PRE BENT, CP TITANIUM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888118095015), received between Dec 6, 2016 and Aug 11, 2020 — classified as 3 injuries.
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. How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break2
- Device Operates Differently Than Expected1
Patient problems
- Cyst(s)1
- Impaired Healing1
- No Information1
- Sensitivity of Teeth1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2020Break; Break
IT WAS REPORTED AN IPS IMPLANT BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 10393668 ↗InjuryDec 20, 2016Break
RECONSTRUCTION PLATE BROKE. PATIENT WAS COMPLIANT HOWEVER THE DOCTOR BELIEVES THE PATIENT MIGHT HAVE GRINDED OR CLINCHED DURING THE NIGHT CAUSING STRESS. PLATE WAS REMOVED AND REPLACED.
Patient problems: No Information
MAUDE report 6191460 ↗InjuryDec 6, 2016Device Operates Differently Than Expected
SURGEON USED THE 3MM PRE-BENT LOCKING PLATE AFTER SURGICAL REMOVAL OF AN AMELOBLASTOMA. AFTER THE CASE THE PATIENT RESECTION SHOWED A POSITIVE MARGIN. THE SURGEON HAD TO PERFORM ADDITIONAL SURGERY TO COMPLETE THE REMOVAL OF THE AMELOBLASTOMA, PRE-BENT PLATE WAS REMOVED AND REPLACED.
Patient problems: Cyst(s); Sensitivity of Teeth
MAUDE report 6147445 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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