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IPS 60-000-35-09Recalls & reported problems

KLS-Martin L.P. · IMPLANT, CRANIAL, ONLAY, 00035, PEEK · Class 2 · Implant

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 00888118100375), received between Dec 28, 2017 and Dec 28, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Incorrect Device Or Component Shipped” (1 report).

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

  • Incorrect Device Or Component Shipped1

Patient problems

  • No Code Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 28, 2017Incorrect Device Or Component Shipped; Incorrect Device Or Component Shipped

    INCORRECT PATIENT SPECIFIC IMPLANT WAS DELIVERED TO HOSPITAL. INCORRECT PRODUCT WAS DISCOVERED IN OPERATING ROOM PRIOR TO ANY SURGERY BEING PERFORMED.

    Patient problems: No Code Available

    MAUDE report 7152535 ↗

Other PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE devices

All PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.