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 Problem Swelling/ Edema (4577)

Event Date 12/07/2020

Event Type  Injury  

Event Description

It was reported that a patient had a new medpor implanted on (b)(6) 2020 due to displacement issues with the original implant after brain swelling.

Manufacturer Narrative

Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.

• 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: 13047717
• MDR Text Key: 282551144
• Report Number: 0008010177-2021-00054
• Device Sequence Number: 1
• Product Code: FWP
• UDI-Device Identifier: 07613252457640
• UDI-Public: 07613252457640
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2021

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?: Yes
• Device Model Number: 5444-0-310
• Device Catalogue Number: 54440310
• Device Lot Number: 2007161015
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2020
• 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