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

Model Number	78-10040
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	11/12/2021
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 that the implant did not fit correctly.
Event or Problem Description
It was reported that the implant did not fit correctly.
Additional Manufacturer Narrative
The reported event could be confirmed, as intra-operative images and a post-op ct scan were provided.The intra-operative images showed that the implant was cut along the midline in order to be able to insert the implant.After cutting the implant and inserting the two pieces, it was reported that the ¿angle of the implant sat up too proud¿, and that the implant ¿sat up very tall in the middle, basically there was a large space between the dura and the implant.¿ the reason for cutting the implant along the midline was that the implant was ¿too narrow¿.The patient¿s skull was much wider than the actual implant.An analysis of the implant design and all quality relevant steps was performed.It was found that all steps were performed in accordance with procedures and the implant was designed as requested by the customer.A post-op ct scan was received and evaluated, the scan showed the non-optimal fit of the implant in the posterior temporalis area on both sides of the patient.The implant's planned position was reviewed.There was swelling noticeable in the ct-scan, but it was not explicitly noted.It is not the designer¿s responsibility to evaluate clinical patient conditions (e.G.Brain swelling) and to incorporate them in the design.The post-op ct scan was evaluated regarding swelling, and evidence of swelling was found to be present during surgery.In conclusion, swelling could be a first contributing factor to the reported event.Additionally, it was determined during the investigation that the undercut features of the implant design were also a contributing factor to the reported event.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT KIT, 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: 12910570
• Report Number: 0008010177-2021-00050
• Device Sequence Number: 17021864
• Product Code: GWO
• UDI-Device Identifier: 04546540730794
• UDI-Public: 04546540730794
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 03/04/2022

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: 78-10040
• Device Catalogue Number: 78-10040
• Device Lot Number: 2110151032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/12/2021
• Supplement Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 03/04/2022
• 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