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

Model Number	78-40040
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2020
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 implanted.
Event or Problem Description
It was reported that a peek customized implant did not fit to the patient bone as expected.The implant was burred down and rebuilt so that it could be utilized.No adverse consequences were reported.
Additional Manufacturer Narrative
The reported event ¿out of specified dimensions¿ (¿didn't fit the patient bone¿) could be confirmed, as intraoperative images have been provided for evaluation.In the complaint analysis performed by the peek customized cranial implant design team, it was stated that all the design steps, specifications and test were in accordance with our ti, so their assumption which could have led to the fitting problem of the implant is the following: the implant reaches quite deep into the skull base which can lead to some fitting issues due to surrounding soft tissue.This soft tissue is quite prominent in this area and often affects the fit of the implant.Therefore, surgeons often request not only a 1.5 mm clearance trimming in this area (like in this case) but a trimming up to 10-20 mm to avoid soft tissue impingement.As the or pictures show, it seems that the burred area is exactly the temporal region where the implant reaches deep into the skull base.Additionally, the postoperative ct-scans were provided and have been forwarded to the peek customized cranial implant team for further investigation.The following statement was made: in the ct slides of the post-op scan, you can see that the brain filled the space up to the implant.Due to too much soft tissue and/or a remaining cerebral swelling shown on the scan, it appears that there was not enough space in the temporal area.Therefore, it protrudes at the backside (s.Fig.2 blue arrows) but has a good fit at the frontal part.The date on which the scan was taken was (b)(6).Although the design proposal was uploaded and approved on (b)(6), the surgery took place on (b)(6).So, there are nearly 4 months between the scan date and the surgery.It can happen that the defect-rim can change, and some calcifications can form (the defect had slightly changed - rounded off instead of sharp edges) over such a longer period.This is considered to have a minor effect on the fitting aspect but cannot be excluded.Therefore, the following statement is always listed in the design proposal (translated into english): ct scan date warning the following warning is applicable if the implant design outlined in this proposal is not reviewed and approved by the case surgeon prior to the ct scan age warning date of 2020-04-06.Analysis of your request indicated that the ct scan submitted falls outside of the recommended scan age parameter defined on the implant request from.If manufactured, this implant could exhibit less than optimal implant fit and require additional or time for implant modification as a result of craniofacial bone growth.To improve expected implant fit, a new ct scan should be taken per the stryker cci scan protocol.Otherwise, please be warned that implant fit may not be optimal and increased intra-operative implant modification may be required and should be expected.The device history record for the ¿peek customized cranial implant, xl¿, catalog # 78-40040, lot code # 2002211011 indicates 1 unit was manufactured to specification and accepted into final stock on (b)(6) 2020 with no reported discrepancies.To ensure that the implant dimensions are manufactured according to specification, a 100% dimensional control is performed through structured light scanning for each customized implant.Also, a fit test between the implant and the hostbone is performed.Both tests were successfully passed.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.
Event or Problem Description
It was reported that a peek customized implant did not fit to the patient bone as expected.The implant was burred down and rebuilt so that it could be utilized.No adverse consequences were reported.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT, XL
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 10155497
• Report Number: 0008010177-2020-00028
• Device Sequence Number: 3600055
• Product Code: GWO
• UDI-Device Identifier: 07613327129250
• UDI-Public: 07613327129250
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K152076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

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: Health Professional
• Device Model Number: 78-40040
• Device Catalogue Number: 78-40040
• Device Lot Number: 2002211011
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2020
• Supplement Date Received by Manufacturer: 05/25/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 12/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1