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

Model Number 5444-0-310

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Cerebral Edema (4403); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/30/2021

Event Type  Injury  

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 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.

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 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
• 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: amelia kesti ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 76145120
• MDR Report Key: 13047820
• MDR Text Key: 282644890
• Report Number: 0008010177-2021-00055
• Device Sequence Number: 1
• Product Code: FWP
• UDI-Device Identifier: 07613252457640
• UDI-Public: 07613252457640
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• 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
• Date Manufacturer Received: 03/30/2021
• 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