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IPS 60-000-23-09Recalls & reported problems

KLS-Martin L.P. · IMPLANT, CRANIAL, 00023, PEEK · Class 2 · Implant

Adverse event reports
7
Deaths reported
0
Injuries reported
6
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888118100139), received between May 11, 2018 and Dec 19, 2019 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Issue” (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

  • Adverse Event Without Identified Device or Use Problem3
  • Device Issue1
  • Inadequacy of Device Shape and/or Size1
  • Insufficient Device Problem Information1
  • Patient Device Interaction Problem1
  • Patient-Device Incompatibility1

Patient problems

  • Impaired Healing3
  • Cerebrospinal Fluid Leakage1
  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1
  • Unspecified Infection1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PEEK IMPLANT WAS REMOVED TO ADDRESS PATIENT INFECTION.

    Patient problems: Unspecified Infection

    MAUDE report 9498324 ↗
  • InjuryMar 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT PRODUCT WAS REMOVED DUE TO PATIENT CONDITION.

    Patient problems: Impaired Healing

    MAUDE report 8432601 ↗
  • InjuryJan 14, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    IT WAS REPORTED THAT THE IMPLANT DID NOT FIT THE DEFECT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8244130 ↗
  • MalfunctionNov 30, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

    IT WAS REPORTED THE IMPLANT DID NOT FIT AS EXPECTED. SURGERY WAS COMPLETED WITH ALTERNATE PRODUCT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8121218 ↗
  • InjuryNov 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED DEVICES WERE REMOVED DUE TO PATIENT CONDITION.

    Patient problems: Cerebrospinal Fluid Leakage

    MAUDE report 8103549 ↗
  • InjuryJul 20, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

    IT WAS REPORTED PLATES AND SCREWS FAILED. DEVICES ARE PLANNED TO BE REMOVED IN AUGUST.

    Patient problems: Impaired Healing

    MAUDE report 7706935 ↗
  • InjuryMay 11, 2018Device Issue; Insufficient Device Problem Information; Device Issue; Insufficient Device Problem Information

    IT WAS REPORTED THAT AFTER THE PATIENT RECEIVED RADIATION THE IMPLANT NEEDS TO BE REMOVED AND REPLACED. EXPECTED REMOVAL DATE (B)(6) 2018.

    Patient problems: Impaired Healing

    MAUDE report 7506052 ↗

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.