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 Code	Swelling/ Edema (4577)
Date of Event	12/07/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• 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: 13047717
• Report Number: 0008010177-2021-00054
• Device Sequence Number: 5630396
• Product Code: FWP
• UDI-Device Identifier: 07613252457640
• UDI-Public: 07613252457640
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K143173
• 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
• Report Date (Section B): 12/20/2021

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?: Yes
• Device Model Number: 5444-0-310
• Device Catalogue Number: 54440310
• Device Lot Number: 2007161015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 12/20/2021
• 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