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

Model Number	78-10030
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	09/11/2020
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.
Event or Problem Description
It was reported by the company representative that the fit of the cci was not as intended towards the frontal bone region.The implant was burred down and ultimately used to complete the surgery.
Event or Problem Description
It was reported by the company representative that the fit of the cci was not as intended towards the frontal bone region.The implant was burred down and ultimately used to complete the surgery.
Additional Manufacturer Narrative
The reported event ¿out of specified dimensions¿ (¿the fit was really bad towards the frontal bone region¿) could be confirmed, as intraoperative images have been provided for evaluation (fig.3).In the event description, surgeon had to burr the implant as it did not fit at the frontal bone area.In the design proposal, bone fragments at the frontal bone region are present in the original ct scan (fig.1).These bone fragments were removed in the design skull and should be taken off by the surgeon intraoperatively to achieve optimal fit (fig.2).A warning has also been provided related to the manufactured implant.The following is stated, ¿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.Otherwise, please be warned that implant fit may not be optimal and increased intra-operative implant modification may be required and should be expected.¿ 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 ¿.According to the sales rep, bone fragments were allegedly removed intraoperatively.However, post-op ct scans (fig.4 & 5) reveal otherwise.Bone fragments are still present and most likely contributed to the reported event.The device history record for the ¿peek customized cranial implant, l¿, catalog # 78-10030, lot code # 2009011011 indicates 1 unit was manufactured to specification and accepted into final stock on 2020-sep-04 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.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT KIT, L
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 10655858
• Report Number: 0008010177-2020-00053
• Device Sequence Number: 3680605
• Product Code: GWO
• UDI-Device Identifier: 04546540730787
• UDI-Public: 04546540730787
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121153
• 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): 12/21/2020

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: 78-10030
• Device Catalogue Number: 78-10030
• Device Lot Number: 2009011011
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1