KELYNIAM CSI PEEK-IM1004Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810125922640), received between Nov 30, 2023 and Nov 30, 2023 — classified as 1 injury.

4 other recalls cover devices cleared under the same FDA submission (K103582); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

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

• InjuryNov 30, 2023

  KELYNIAM RECEIVED A REPORT FROM A DISTRIBUTOR / SALES REP THAT A PREVIOUSLY IMPLANTED MEDICAL DEVICE WAS TO BE REMOVED BECAUSE THE PT DEVELOPED AN INFECTION. KELYNIAM MANUFACTURES CUSTOM IMPLANTS BASED ON THE ORDER OF A PHYSICIAN AND ACCORDING TO A CT PROVIDED BY THE SURGEON. THE DESIGN OF THE IMPLANT IS PROVIDED TO THE SURGEON FOR DESIGN VERIFICATION BEFORE THE IMPLANT IS ACTUALLY PRODUCED. IF THE DESIGN IS ACCEPTABLE THE SURGEON SIGNS THE CASE ORDER FORM. KELYNIAM RECEIVED A REPORT THAT A PATIENT THAT WAS IMPLANTED IN (B)(6) OF 2023 HAD DEVELOPED AN INFECTION. A NEW DUPLICATE IMPLANT WAS REQUESTED. AN INTERNAL INVESTIGATION WAS INITIATED. THE INVESTIGATION INDICATED THAT THE DESIGN, AS APPROVED BY THE SURGEON WAS ACCURATE. THIS TYPE OF IMPLANT IS A CUSTOM DEVICE SOLD AS NON-STERILE AND IS SPECIFIC TO A SINGLE PATIENT ON THE ORDER OF A SINGLE SURGEON. KELYNIAM HAS ATTEMPTED TO CONTACT THE SURGEON AND WILL CONTINUE TO DO SO. IF ANY RELEVANT INFORMATION IS OBTAINED THIS REPORT WILL BE AMENDED.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 18247466 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103582. One submission often covers many models, so check the product and lot details in each record.

• Z-1871-2018 · Jun 10, 2017 · Terminated
  Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002
• Z-1870-2018 · Jun 10, 2017 · Terminated
  Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)
• Z-1873-2018 · Jun 10, 2017 · Terminated
  Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004
• Z-1872-2018 · Jun 10, 2017 · Terminated
  Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003