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

Model Number 55-06250

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 03/20/2023

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 313602433
• Report Number: 0008010177-2023-00022
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 04546540365828
• UDI-Public: 04546540365828
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/19/2023
• Supplement Dates Manufacturer Received: 03/20/2023
• Supplement Dates FDA Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention