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

Catalog Number	54440310
Medical Device Problem Codes	Fracture (1260); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the stryker representative that the surgeon was having problems with implanting the device.This resulted in a delay in surgery.
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.
Event or Problem Description
It was reported by the stryker representative that the surgeon was having problems with implanting the device.This resulted in a delay in surgery.
Additional Manufacturer Narrative
Update: h6.The reported event that the customized implant was thicker as expected and a part of the implant seemed partly cracked could not be confirmed as a post-operative ct scan or pictures were not provided.The surgeon reported they had to trim or shave part of the implant to make it fit.A device history report (dhr) review was performed.Within the review no deviations were found, the required tests were performed and did pass without any discrepancies.A design analysis was performed by a custom implant designer of stryker.Within this analysis the custom implant designer shared images of the design proposal that was approved by the surgeon, including ct scans of the patient¿s defect.There were no deviations from the standard design process found.Summarizing all obtained information, the root cause of the reported event could not be determined.Based on the performed investigation, the assessment of the designer and the dhr review there is no indication for an incorrectly working product or design, material or manufacturing related issue.

• 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: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 19375571
• Report Number: 0008010177-2024-00048
• Device Sequence Number: 12667268
• Product Code: FWP
• UDI-Device Identifier: 07613252457640
• UDI-Public: 07613252457640
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K153508
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 54440310
• Device Lot Number: 2403181029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2024
• Supplement Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other; Required Intervention
• Patient Sex: Unknown