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

Model Number	78-50030
Medical Device Problem Codes	Nonstandard Device (1420); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2020
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 still implanted.
Event or Problem Description
It was reported by the company representative that a patient presented with a gun shot wound.It was decided that a peek priority implant was to be used.The surgeon was provided two design options.The surgeon chose the design he felt best fit the area/fragment.When the device came in there was an unexpected gap in the front.He used standard plates to bridge the gap, and the procedure was completed successfully.It was determined that this was a design issue and that the device was manufactured correctly according to the design.
Additional Manufacturer Narrative
The reported event ¿design issue¿ could not be confirmed.In the event description, it has been mentioned that this complaint is a design issue and not a product issue.Thus, the design proposal has been analyzed by the customs design team.In the complaint analysis performed by the peek customized cranial implant design team, it was stated that ¿(¿) the implant design was performed according to freqi 08-500.The implant is also designed symmetric to the contralateral side; (¿)¿ in the event description, the plate is described to have a gap in the front.According to the complaint analysis, as the surgeon has opted to use standard plates to bridge the gap, this may have led to the implant sitting proud in the back.All appendices were shown in the design proposal.However, in the design skull appendix section, the complete defect was not demonstrated (loose bone is not shown).The custom design team mentioned that this is not a severe issue and has no influence on the design or the current complaint.Further, the required extra clearance was not stated properly in the design proposal, thus the surgeon is not aware about the clearance and does not know the reason behind the trimming.It is stated in the complaint analysis that ¿(¿) ideal would have been a comment in the design specification table: ¿5mm implant trimming due to unsupported bone and clearance to provide room for repositioning¿.(¿) (fig.1)¿ the reported device is a peek priority, thus the second feedback was not properly documented and may have raised different expectations on the implant design.The surgeon has expected to receive an implant similar to the device presented in the feedback document and not as the one in the design proposal.Surgeon has requested option 2.It was not stated that the clearances for option 1 has been used for option 2.In order to prevent a misinterpretation of the feedback document in the future, the custom design team has mentioned that the document will be subject for improvement as well as to engage a second designer to review it ensuring that questions and images are precise as well as to avoid any misunderstanding (false expectations) from the customer.Further, they will also review the feedback document in terms of user handling and that it is an early sketch of the implant, not the final one, i.E.Certain changes may apply.Based on the performed statistical investigation and the dhr review there is no indication for an incorrectly working product or any systematic design, material or manufacturing related issue.Therefore, no corrective and / or preventive actions are deemed necessary at that time.The complaint is added to the complaint trend.
Event or Problem Description
It was reported by the company representative that a patient presented with a gun shot wound.It was decided that a peek priority implant was to be used.The surgeon was provided two design options.The surgeon chose the design he felt best fit the area/fragment.When the device came in there was an unexpected gap in the front.He used standard plates to bridge the gap, and the procedure was completed successfully.It was determined that this was a design issue and that the device was manufactured correctly according to the design.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT PRIORITY, L
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; DE D-79111
• MDR Report Key: 9683958
• Report Number: 0008010177-2020-00009
• Device Sequence Number: 2815377
• Product Code: GWO
• UDI-Device Identifier: 07613327129267
• UDI-Public: 07613327129267
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K152076
• 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): 06/25/2020

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: No Information
• Device Model Number: 78-50030
• Device Catalogue Number: 78-50030
• Device Lot Number: 2001031020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1