MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG MEDPOR PRIORITY CUSTOMIZED - PLUS - XL; IMPLANT

Catalog Number 5444-5-410

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2023

Event Type  malfunction  

Manufacturer Narrative

Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.H3 other text : not available.

Event Description

It was reported by the sales representative that the implant was not manufactured correctly.The implant was built up too far posterior and the surgeon noted it was not possible to complete the surgery using the implant.There was an alternative option to complete the surgery successfully.No significant surgery delay was reported and no adverse events were reported.

Manufacturer Narrative

The implant exhibited a greater prominence compared to the natural skull.This resulted from the necessity of seamlessly integrating the implant into a slightly asymmetrical skull.Summarizing all obtained information, the asymmetrical skull of the patient caused the design team to design an implant with more projection.The additional projection and the plus feature ordered did not allow the surgeon to close the skin flap as planned.Based on the performed investigation, there is no indication for an incorrectly working a product or design, material or manufacturing related issue.H3 other text : not available.

Event Description

It was reported by the sales representative that the implant was not manufactured correctly.The implant was built up too far posterior and the surgeon noted it was not possible to complete the surgery using the implant.There was an alternative option to complete the surgery successfully.No significant surgery delay was reported and no adverse events were reported.

• Brand Name: MEDPOR PRIORITY CUSTOMIZED - PLUS - XL
• 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: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 18140170
• MDR Text Key: 328169118
• Report Number: 0008010177-2023-00072
• Device Sequence Number: 1
• Product Code: FWP
• UDI-Device Identifier: 07613327465570
• UDI-Public: 07613327465570
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191916
• 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: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5444-5-410
• Device Lot Number: 2309291020 (B)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2023
• 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