MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG MEDPOR CUSTOMIZED-MIDFACE; IMPLANT

Model Number	5444-0-510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Skin Infection (4544)
Date of Event	11/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.
Event or Problem Description
It was reported that after a medpor single stage was implanted the patient was treated with radiotherapy and contracted an infection that led to a planned revision surgery.Medical intervention and adverse consequences to the patient were reported, but the surgeon attributed the infection to the radiotherapy.
Additional Manufacturer Narrative
Based on the information provided by the stryker medpor expert and stryker's medical expert, they concurred that the product did not cause or contribute to the reported event, as an infection at a medpor implant site is thought to be caused by either contamination of the implant during the initial surgery, especially from oral mucosa if it is an intraoral approach, or by later contamination through a surgical wound dehiscence or exposure of the implant due to breakdown of the overlying tissue.
Event or Problem Description
It was reported that after a medpor single stage was implanted the patient was treated with radiotherapy and contracted an infection that led to a planned revision surgery.Medical intervention and adverse consequences to the patient were reported, but the surgeon attributed the infection to the radiotherapy.

• Brand Name: MEDPOR CUSTOMIZED-MIDFACE
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: amelia kesti ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 76145120
• MDR Report Key: 12925190
• Report Number: 0008010177-2021-00052
• Device Sequence Number: 12196811
• Product Code: FWP
• UDI-Device Identifier: 07613252457657
• UDI-Public: 07613252457657
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2022

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: 5444-0-510
• Device Catalogue Number: 54440510
• Device Lot Number: 2103301042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown