MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PLT/SAG.SPLIT FOR 2.0MM MP; IMPLANT

Catalog Number	92-55556
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/21/2025
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 the patient developed an infection that needs i&d of mandible and removal of plate.
Additional Manufacturer Narrative
Additional information: h4, h6, the reported infection could be confirmed.Stryker¿s senior global medical director reviewed the case and confirmed that the infection resulted from the patient not taking prescribed antibiotics, indicating it was unrelated to the device.As the event is an adverse effect associated with the diagnosis or surgical procedure, it does not meet complaint criteria and the investigation was closed accordingly.Based on the investigation, there is no indication for an incorrectly working product or any design, material, or manufacturing-related issue.Therefore, no corrective and/or preventive actions are deemed necessary at this time.
Event or Problem Description
No new information.

• Brand Name: PLT/SAG.SPLIT FOR 2.0MM MP
• 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: elena drewenskus ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 23030873
• Report Number: 0008010177-2025-00109
• Device Sequence Number: 9820070
• Product Code: JEY
• UDI-Device Identifier: 07613154482016
• UDI-Public: 07613154482016
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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): 10/23/2025

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
• Device Catalogue Number: 92-55556
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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