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

Model Number	5444-0-110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/23/2023
Type of Reportable Event	Serious Injury
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 a revision surgery was performed to remove the medpor implant that was believed to be infected, and replace with a peek implant.
Additional Manufacturer Narrative
The reported event cannot be confirmed, since no evidence of the infection, e.G.Lab results, could be provided.Sales representative reported that medpor implant was removed due to infection in the same surgery that a peek implant was supposed to be implanted.Respective information per ¿infection complaints _ checklist customer¿ (cmfqf 13-003)¿ was requested from the sales rep regarding the infection organism and lab results.However, the sales representative could not provide any of the requested information.Stryker¿s medical expert was consulted regarding this case and confirmed that the implant did not cause or contribute to the infection, which only now occurred ~ 8 years after implantation.Based on the investigation including the assessment of the stryker healthcare professional there is no indication for any design, material or manufacturing related issue.H3 other text: not available.
Event or Problem Description
It was reported a revision surgery was performed to remove the medpor implant that was believed to be infected, and replace with a peek implant.

• Brand Name: MEDPOR CUSTOMIZED CRANIAL-S
• 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: 17165663
• Report Number: 0008010177-2023-00043
• Device Sequence Number: 5817988
• Product Code: FWP
• UDI-Device Identifier: 07613252457626
• UDI-Public: 07613252457626
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K143173
• 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): 08/23/2023

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 Model Number: 5444-0-110
• Device Catalogue Number: 54440110
• Device Lot Number: 1501101001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 08/23/2023
• 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