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

Model Number	78-50040
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
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 in patient.
Event or Problem Description
It was reported that the implant dimensions were incorrect and did not properly fit the patient's anatomy.There was a delay during surgery of around 2 hours, but no adverse consequences were reported.The implant was cut into pieces to complete the surgery.
Additional Manufacturer Narrative
The reported event could be confirmed, as an intra-operative image was provided.On 26-jan-2022, two stryker sales representatives reported that the peek implant appeared shaped inward, did not fit patient's anatomy, and was incorrectly curved.The extra or time as a result was at least 2 hours, which was later confirmed by the surgeon.An analysis of the implant design and all quality relevant steps showed that all steps were performed in accordance with internal procedures.The implant is designed as requested through.In addition, the ct scan showed some brain swelling, although this was not explicitly mentioned.At that point of investigation, it was assumed that brain swelling and the bilateral extend of the peek implant could likely have contributed to the event.On 09-mar-2022, a follow-up call with the surgeon was held with the stryker representatives.The surgeon clarified in this call that the implant was 20-30 % too large.He provided an intra-operative image and explained that he had to cut the implant to reduce volume and cover the defect.He further stated that the angles didn't fit.He commented the result as ¿not a bad outcome¿ and stated that the modifications have no impact on the patient outcome.At the end of the call, options were pointed out to the surgeon and rep to support in future bilateral cases, such as attending a design session; ordering a host bone model or use a medpor multi-piece implant instead.Surgeon and rep were open to these options and will consider these for future implants.In conclusion, the statements made by the surgeon in the follow-up call on 09-mar-2022 supported that swelling could be a contributing factor to this event, although this was not confirmed by the surgeon.Whether anatomical changes have occurred can only been evaluated with a post-op ct scan.This was requested, but could not be obtained by the sales representative due to the hospital¿s strict data privacy policy at the time of closure of this complaint.
Event or Problem Description
It was reported that the implant dimensions were incorrect and did not properly fit the patient's anatomy.There was a delay during surgery of around 2 hours, but no adverse consequences were reported.The implant was cut into pieces to complete the surgery.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT PRIORITY, XL
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: amelia kesti ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 76145120
• MDR Report Key: 13516761
• Report Number: 0008010177-2022-00005
• Device Sequence Number: 12393246
• Product Code: GWO
• UDI-Device Identifier: 07613327129274
• UDI-Public: 07613327129274
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K152076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2022

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: 78-50040
• Device Catalogue Number: 78-50040
• Device Lot Number: 2110051017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 02/11/2022
• Supplement Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown