MAUDE Adverse Event Report: STRYKER LEIBINGER GMBH & CO. KG; PLATE, BONE

Model Number 78-30020

Device Problem Material Discolored (1170)

Patient Problem No Patient Involvement (2645)

Event Date 11/01/2018

Event Type  malfunction  

Event Description

A custom mandible plate implant was sterilized in preparation for surgery.After the sterilization cycle, the implant was discolored and did not look like a normal implant.The implant is made from anodized titanium and normally has a gold color.After processing, this implant became purple/blue and splotchy looking on the surface.The implant was not used.There was no patient involvement.The surgery was scheduled for a few days later.Manufacturer would like to get the device for evaluation.

• Brand Name: NA
• Type of Device: PLATE, BONE
• Manufacturer (Section D): STRYKER LEIBINGER GMBH & CO. KG; 2825 airview blvd.; portage MI 49002
• MDR Report Key: 8334689
• MDR Text Key: 136020690
• Report Number: 8334689
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 78-30020
• Device Catalogue Number: 78-30020
• Device Lot Number: 1811021004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2019
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16425 DA