MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PEEK CUSTOMIZED CRANIAL IMPLANT, M

Model Number	78-40020
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2022
Type of Reportable Event	Malfunction
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 company representative that the peek cci did not fit as expected.There is no other known information at this time.
Event or Problem Description
It was reported by the company representative that the peek cci did not fit as expected.There is no other known information at this time.
Additional Manufacturer Narrative
The reported event ¿implant did not fit on the left side¿ could be confirmed based on the provided intraoperative image.However, the reported event ¿left side was flat compared to design proposal¿ could not be confirmed based on the provided intraoperative image.In further communication with the sales representative, it could be clarified during the investigation based on the intraoperative image that a gap is present between the implant and the defect, that was not covered.It could not be clarified whether the soft tissue in the temporalis area was fully cleared.The implant¿s design was strongly curved in the temporalis area, to match the defects void.Therefore, a full clearance of that area before implantation is essential.Further, it could be clarified that the free-floating tool, which was identified in the design review, was removed.It is not clear whether all calcifications, which were highlighted in the design proposal, were removed prior implantation.It was noted that the ct scan provided was obtained on (b)(6) 2021, whereas the design got created on (b)(6) 2021.There is a period of roughly 9 months in between, in which anatomical changes can appear.The sales rep confirmed that this ct scan was provided by the surgeon.The ct scan date warning was placed in the design proposal and is applicable.In conclusion, the implant was designed as requested by the customer.The main contributing factor is assumed to be the age of the ct scan.However, without a post-op or a later ct scan, no potential changes in the patient¿s anatomy can be investigated.Overall, the implant was designed according to all quality instructions, and manufactured to specification.H3 other text : device not available.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT, M
• 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: 13973097
• Report Number: 0008010177-2022-00011
• Device Sequence Number: 6229756
• Product Code: GWO
• UDI-Device Identifier: 07613327129335
• UDI-Public: 07613327129335
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112557
• 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): 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 78-40020
• Device Catalogue Number: 78-40020
• Device Lot Number: 2112101009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2021
• 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
• Patient Sex: Unknown