IPS 60-620-03-04Recalls & reported problems
KLS-Martin L.P. · IMPLANT, CRANIAL, LARGE, PEEK · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888118094988), received between Nov 8, 2019 and Nov 8, 2019 — classified as 1 injury.
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 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PRODUCT WAS REMOVED DUE TO PATIENT CONDITION.
Patient problems: Unspecified Infection
MAUDE report 9298668 ↗
Other METHYL METHACRYLATE FOR CRANIOPLASTY devices
- Direct Inject 79-45905Stryker Leibinger GmbH & Co. KG · METHYL METHACRYLATE FOR CRANIOPLASTY1 recall7 reports
- CRANIOS Reinforced 615.05.01SSynthes GmbH · METHYL METHACRYLATE FOR CRANIOPLASTY17 reports
- CRANIOS Reinforced 615.10.01SSynthes GmbH · METHYL METHACRYLATE FOR CRANIOPLASTY11 reports
- Direct Inject 79-45910Stryker Leibinger GmbH & Co. KG · METHYL METHACRYLATE FOR CRANIOPLASTY7 reports
- CRANIOS Reinforced 615.03.01SSynthes GmbH · METHYL METHACRYLATE FOR CRANIOPLASTY4 reports
- HYDROSET 79-43910Stryker Leibinger GmbH & Co. KG · METHYL METHACRYLATE FOR CRANIOPLASTY4 reports
- StaGraft DBM Putty 92-2004Biomet Orthopedics, LLC · Methyl Methacrylate For Cranioplasty3 reports
- HYDROSET 79-43905Stryker Leibinger GmbH & Co. KG · METHYL METHACRYLATE FOR CRANIOPLASTY2 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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