MAUDE Adverse Event Report: STRYKER LEIBINGER GMBH & CO. KG TITANIUM MESH; PLATE, BONE

Model Number 54-00646

Device Problems Material Separation (1562); Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994)

Event Date 10/10/2016

Event Type  Injury  

Event Description

Patient called to report an adverse event involving her stryker titanium mesh which was implanted (b)(4) 2016.Patient stated that immediately after the device was implanted, she experienced severe pain and pressure.She stated that she was followed for 7 years and saw different surgeons who told her the device was breaking apart.The patient stated she eventually had allergy testing done last year and it was discovered she had an allergy to the device.The patient stated she had the device explanted 3 weeks ago on (b)(4) 2023 and says her symptoms have improved and that the pain and pressure are almost completely gone.

• Brand Name: TITANIUM MESH
• Type of Device: PLATE, BONE
• Manufacturer (Section D): STRYKER LEIBINGER GMBH & CO. KG
• MDR Report Key: 16733888
• MDR Text Key: 313330316
• Report Number: MW5116609
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 54-00646
• Device Catalogue Number: 54-00646
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Sex: Female