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

Model Number 78-30020

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Unspecified Infection (1930)

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.

Event Description

It was reported by the company representative that the patient developed an infection post operative, and a revision surgery was performed to remove the product.

Manufacturer Narrative

The reported event could not be confirmed.Additional information (e.G.Initial implantation date, date the infection was discovered, and laboratory results) were requested regarding the reported event.Further, the sales rep was asked to fill-out the ¿infection complaints ¿ checklist customer¿ (cmfqf (b)(6) ).No further information could be provided except the initial implantation date, (b)(6) 2020.The ¿infection complaints ¿ checklist investigator¿ (cmfqf (b)(6) ) 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 monitoring, 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 for the device.Infection is a known adverse event related to this procedure.In general, infections, foreign body reactions, and inflammations following the insertion of implants are known adverse events associated with these procedures.They are documented in the instructions for use and have been considered in the risk evaluation of the relevant stryker product.This type of adverse event may rather be clinically related than implant related.Based on statistical evaluation, there is no indication for an incorrectly working product or 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.H3 other text : device not available for return.

Event Description

It was reported by the company representative that the patient developed an infection post operative, and a revision surgery was performed to remove the product.

• Brand Name: CUSTOMIZED MAND. RECON PLATE20, HEMI
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 11045851
• MDR Text Key: 222644291
• Report Number: 0008010177-2020-00066
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07613252599647
• UDI-Public: 07613252599647
• Combination Product (y/n): N
• PMA/PMN Number: K132519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 78-30020
• Device Catalogue Number: 78-30020
• Device Lot Number: 2007251001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other