MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG CUSTOMIZED MAND. RECON PLATE20, HEMI; IMPLANT

Catalog Number	78-30020
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Device evaluated by mfr: device is implanted in patient.
Event or Problem Description
It was reported by a company representative that a patient developed a post-surgical infection after initial implantation with an implant.The original procedure was reported as completed successfully without a delay, but approximately one month later during a revision surgery the bone was removed.
Event or Problem Description
It was reported by a company representative that a patient developed a post-surgical infection after initial implantation with an implant.The original procedure was reported as completed successfully without a delay, but approximately one month later during a revision surgery the bone was removed.
Additional Manufacturer Narrative
The reported event could not be confirmed.Further information (e.G.Initial implantation date, postoperative images after initial implantation, surgeon¿s reports) was requested regarding the reported event.The sales rep was asked to fill-out the ¿infection complaints ¿ checklist customer¿ (cmfqf 13-0003).However, no further information was received.The ¿infection complaints ¿ checklist investigator¿ (cmfqf 13-002) was completed by the manufacturer for the affected device.For infection complaints expanded investigations were performed.This is to assure that neither the reported device nor all related manufacturing (e.G.Environmental monitor-ing, sterilization validations tests) process steps could have caused the event.Indications for any device or manufacturing problems were not found.The reported device is delivered non-sterile.The related instructions for use (90-02023) include the appropriate cleaning, disinfection, and sterilization instructions.The evaluation has shown that there are no indications for any systematic design, material, or manufacturing related issue.Therefore, no corrective and/or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.

• Brand Name: CUSTOMIZED MAND. RECON PLATE20, HEMI
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 8433367
• Report Number: 0008010177-2019-00008
• Device Sequence Number: 11017765
• Product Code: JEY
• UDI-Device Identifier: 07613252599647
• UDI-Public: 07613252599647
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K132519
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 78-30020
• Device Lot Number: 1806081005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 06/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1