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

Model Number	5444-0-110
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
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 that during the procedure to remove and replace the implant, it was discovered the new implant did not fit as expected and could not be used.A revision surgery will need to be performed.
Event or Problem Description
It was reported that during the procedure to remove and replace the implant, it was discovered the new implant did not fit as expected and could not be used.A revision surgery will need to be performed.
Additional Manufacturer Narrative
It was confirmed that the defect site was not cranialized or obliterated according to the warning ¿sinus reconstruction¿ in the design proposal.The sales rep agreed that not removing the bone was the main contributing factor resulting the implant not to fit into the defect site summarizing all obtained information, the complaint root cause of the complaint could be determined.Without the surgeon removing the bone fragments the implant did not fit as expected.

• 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 ; 76145120
• MDR Report Key: 14917627
• Report Number: 0008010177-2022-00020
• Device Sequence Number: 16652026
• Product Code: FWP
• UDI-Device Identifier: 07613252457626
• UDI-Public: 07613252457626
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 10/13/2022

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: 2205191047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 10/13/2022
• 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