MAUDE Adverse Event Report: KELYNIAM GLOBAL, INC. CUSTOMIZED CRANIOFACIAL (CCI), CUSTOMIZED SKULL IMPLANT (CSI); PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE

Model Number	PEEK-IM1004-TABS
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	11/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
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.

• Brand Name: CUSTOMIZED CRANIOFACIAL (CCI), CUSTOMIZED SKULL IMPLANT (CSI)
• Common Device Name: PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE
• Manufacturer (Section D): KELYNIAM GLOBAL, INC.; 97 river road; canton CT 06019
• MDR Report Key: 18247466
• Report Number: MW5148646
• Device Sequence Number: 6132295
• Product Code: GWO
• UDI-Device Identifier: 00810125922640
• UDI-Public: 00810125922640
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PEEK-IM1004-TABS
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/30/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male