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

Model Number	78-10040
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
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.Device is implanted.
Event or Problem Description
It was reported that the implant did not fit as expected and portions of the implant were cut intra-operatively in order to implant the device successfully.There was no adverse event reported.
Event or Problem Description
It was reported that the implant did not fit as expected and portions of the implant were cut intra-operatively in order to implant the device successfully.There was no adverse event reported.
Additional Manufacturer Narrative
The reported event could be confirmed, as photos of the modification of the implant and imaging of intra-operative swelling were provided.The intraoperative images showed the performed cuts on the implant and the performed refixation of the implant using stryker burr hole covers 53-34520 and mesh 56-90614.At the time of designing the implant, the ct scan was 10 days old.Therefore, the following note was placed on p.5 of the design proposal regarding swelling: "the ct scan provided [¿] shows significant swelling of the brain.At time of the surgery ensure the implant fits freely in the defect/void.[¿]".However, imaging of the skull showed that swelling was still present during surgery near the posterior defect void.Further, the sales rep confirmed that swelling was the reason for the triangular cut of the implant to allow the swelling more space.The implant¿s design was assessed regarding the effect of brain swelling.No further instructions from the surgeon were given on the design of the implant for surgical considerations and no design session was held.Therefore, the implant was designed symmetrically to the contralateral side.In conclusion, the implant was designed as requested by the customer.The root cause can be attributed to the patient condition and the swelling that was still present during surgery.Overall, the implant was designed according to all quality instructions, and manufactured to specification.Based on the investigation steps performed, there is no indication of an incorrectly working product or any design, material, or manufacturing-related issue.Therefore, no corrective and/or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.H3 other text: device is implanted.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT KIT, XL
• 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: 12626568
• Report Number: 0008010177-2021-00044
• Device Sequence Number: 19199486
• Product Code: GWO
• UDI-Device Identifier: 04546540730794
• UDI-Public: 04546540730794
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121153
• 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): 03/17/2022

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
• Operator of Device: Health Professional
• Device Model Number: 78-10040
• Device Catalogue Number: 78-10040
• Device Lot Number: 2108121003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 03/18/2022
• 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
• Patient Sex: Unknown