MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PLATE, CURVED, 10 HOLE, UPPERFACE; IMPLANT

Model Number	55-06250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/20/2023
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 had implants placed a year ago and was experiencing pain.Patient requested for the devices to be removed.Surgeon performed a second surgery to remove the devices and surgeon noted there were no issues with the devices.
Event or Problem Description
It was reported that the patient had implants placed a year ago and was experiencing pain.Patient requested for the devices to be removed.Surgeon performed a second surgery to remove the devices and surgeon noted there were no issues with the devices.
Additional Manufacturer Narrative
Update: h6 corrected data: it has been confirmed by a medical expert that the stryker device did not cause and/or contribute to the event as described; therefore, the mdr record that was filed, is not valid.Please see communication attached in the communication log.H3 other text : not available.

• Brand Name: PLATE, CURVED, 10 HOLE, UPPERFACE
• 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: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 16771383
• Report Number: 0008010177-2023-00022
• Device Sequence Number: 20429793
• Product Code: JEY
• UDI-Device Identifier: 04546540365828
• UDI-Public: 04546540365828
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K022185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2023

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: 55-06250
• Device Catalogue Number: 55-06250
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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