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	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
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.
Event or Problem Description
It was reported by the company representative that the implant did not fit correctly and surgery was not completed.The patient will require a new implant.
Event or Problem Description
It was reported by the company representative that the implant did not fit correctly and surgery was not completed.The patient will require a new implant.
Additional Manufacturer Narrative
The reported event the ¿implant did not fit correctly¿ cannot be confirmed as no images were provided from during the surgery and the scan of the follow-up scan showed no significant changes in the anatomy.A review of the request details in erequest for lot code # 2012091002 showed that the surgeon explicitly ¿confirmed [¿] bone fragments will not be removed over void however bone at defect edge is stable¿ and further confirmed the ¿minimum thickness peek implant with reduced profile.¿ therefore, the peek implant was designed over the bone fragments and at minimum thickness size of 4mm and tapered around the perimeter to 3.3mm.In the complaint analysis performed by the peek customized cranial implant design team, it was stated that ¿[t]he implant design and all quality relevant design steps were performed in accordance to our freqi procedures.The implant is designed as it got requested during the design session with the surgeon¿.In the design proposal all pictures and a description of the designed peek implant were provided.The implant¿s design was approved verbally during design session.Further, the analysis states that the scan was taken on (b)(6) 2020 and delivered on (b)(6) 2020, so approximately 4 weeks were between the scan and the surgery.This is approximate as exact surgery date is unknown.The analysis stated, that ¿[d]ue to the anatomy of the patient, the requirement to not remove any bone and the request that the implant should be more flatten, there is highly the chance that even minor changes in the bone fragments and/ or defect rim can lead to a not optimal fit of the implant.¿ this is a possible root cause that could have led to the reported issue.Additionally, a newer scan was taken on (b)(6) 2021 and received within the follow-up request with id (b)(6).In the analysis performed by the peek customized cranial implant design team, this scan was segmented, and the skull compared to the scan that was taken on (b)(6) 2020 and used for the design this complaint is related to.Only slight differences under 1 mm can be seen.Additional information was received from the sales representative that the device under complaint was discarded and no pictures of the issue during surgery were taken.Further information from the surgeon that would have specified the issue was not received.In a brief call with the sales representative she stated that the revision surgery went fine.Related to the lot code number, relevant inspection and quality documents have been reviewed.The review showed that the implant and the host bone model were manufactured in accordance to the specification.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 seemed necessary at that time.The complaint is added to the complaint trend.In summary, the implant this complaint refers to was designed according to the surgeon¿s request during the design session.As limited information is available and the product was not returned for investigation, the root cause for the reported issue cannot be determined.H3 other text: device unavailable for return.

• 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: 11169810
• Report Number: 0008010177-2021-00002
• Device Sequence Number: 17159244
• Product Code: GWO
• UDI-Device Identifier: 04546540730787
• UDI-Public: 04546540730787
• Combination Product (Y/N): N
• 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): 04/22/2021

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: 2012091002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 04/22/2021
• 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: Other