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

Catalog Number	78-10040
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2018
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 that the custom implant did not fit the way the surgeon wanted.Per the surgeon, "it was too flat".The procedure was completed by the surgeon burring down the posterior portion of the cci to reduce the gap and to create a less palpable shape.
Event or Problem Description
It was reported that the custom implant did not fit the way the surgeon wanted.Per the surgeon, "it was too flat".The procedure was completed by the surgeon burring down the posterior portion of the cci to reduce the gap and to create a less palpable shape.
Additional Manufacturer Narrative
The reported event could not be confirmed, because the information provided was not sufficient.The device history record for the ¿peek customized cranial implant kit, xl¿, catalog # 78-10040, lot code # 1803201008 indicates 1 unit was manufactured to specification and accepted into final stock on 2018-apr-03 with no reported discrepancies.To ensure that the implant dimensions are manufactured according to specification, for each customized implant a 100% control is performed through structured light scanning.This test was successfully passed.Also a fitting test with the corresponding host bone was passed.While the preoperative ct scan was performed on (b)(6) 2018, the cranioplasty did not take place until the recommended date of (b)(6) 2018, but was performed on (b)(6) 2018.In this case the scan age warning within the design proposal is applicable including the remark that ¿implant fit may not be optimal and increased intra-operative implant modification may be required and should be expected¿.However this does not completely explain the reported ¿implant is too flat¿.The obtained information was not sufficient to determine the root cause for this complaint.For a profound assessment of this case a postoperative ct scan is crucial.Should this scan be delivered in the future, this complaint will be reopened for further assessment.Based on the performed investigation and the dhr review including a 100% dimensional control of the implant through structured light scanning there is no indication for a not correctly working product or any systematic design, material or manufacturing related issue.Therefore no further corrective and / or preventive actions are deemed necessary at that time.The complaint is added to the complaint trend.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT KIT, XL
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 7919658
• Report Number: 0008010177-2018-00092
• Device Sequence Number: 1400115
• Product Code: GWO
• UDI-Device Identifier: 04546540730794
• UDI-Public: 04546540730794
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 03/19/2019

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 Catalogue Number: 78-10040
• Device Lot Number: 1803201008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 03/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention