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

Model Number	5444-0-310
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Cerebral Edema (4403); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/30/2021
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.Device not available.
Event or Problem Description
It was reported that the patient had most anterior fixation as well as most posterior fixation pulling out from patient¿s bone.The surgeon stated that this was possibly due to pressure from brain swelling.
Additional Manufacturer Narrative
The complaint event could be confirmed.The complaint department has already covered two previous reported events with a medpor customized product (lot# 2007161015) for this patient.According to the previous investigations, the patient had back-to-back issues with brain swelling.The surgeon used an external ventricular drain (evd) to drain extra cerebrospinal fluid (csf) from the brain.Even though the implant was fixated appropriately with more screws and plates than recommended, the implant loosened due to the pressure of the brain fluid in the area where the swelling was present.Furthermore, a review of the manufacturing records confirmed the lot meets all final release specifications.Summarizing all obtained information, the root cause of the reported event was the swelling present laterally and posteriorly to the patients left eye prior to the implant.Additionally, it is the surgeon¿s responsibility to reduce the swelling prior to implanting the device.
Event or Problem Description
It was reported that the patient had most anterior fixation as well as most posterior fixation pulling out from patient¿s bone.The surgeon stated that this was possibly due to pressure from brain swelling.

• Brand Name: MEDPOR CUSTOMIZED CRANIAL-L
• 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: 13047820
• Report Number: 0008010177-2021-00055
• Device Sequence Number: 13829521
• Product Code: FWP
• UDI-Device Identifier: 07613252457640
• UDI-Public: 07613252457640
• 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): 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
• Device Model Number: 5444-0-310
• Device Catalogue Number: 54440310
• Device Lot Number: 2011091030
• 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: 03/30/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 03/04/2022
• 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