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	02/08/2021
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 during the cranioplasty, the peek cranial implant plate did not fit well.The surgeon had to remove bone from the surgical site.The surgeon also had to drill down and thin down the plate to get the plate to fit.The plate is implanted and no other information is known at this time.
Event or Problem Description
It was reported by the company representative that during the cranioplasty, the peek cranial implant plate did not fit well.The surgeon had to remove bone from the surgical site.The surgeon also had to drill down and thin down the plate to get the plate to fit.The plate is implanted and no other information is known at this time.
Additional Manufacturer Narrative
The reported issue could be confirmed as a post-op scan showed the implant in its modified shape fitting the defect.The reported event was further specified by the surgeon himself.He confirmed the outline of the area, where he had to remove some bone and thin down the implant, being within the red outline (more on the left forehead area).Further, he stated that ¿there were no unexpected changes to the brain or skull intra-operatively as compared with the pre-operative scan.¿ the surgical delay was around 15-20 minutes.The surgeon provided a post-op scan and indicated one ¿will notice that there is also some overlap of bone down the two sides (by the temporal fossa floor) as the plate is slightly longer than the actual defect.¿ the peek design team performed an analysis of the implant¿s design.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 by the surgeon¿.The analysis points out that ¿segmented bone calcification (located mostly in the patients right sphenoidal bone area) [are] shown in the design proposal in red on page 3.¿ it was further identified that these calcifications had contact with the implant.Assuming these fragments were not removed prior to inserting the peek implant, this could have contributed to the reported event.This would further explain the surgeon¿s note on an ¿overlap of bone down by the two sides¿ and the implant being ¿slightly longer than the actual defect¿.In addition, the post-op scan was evaluated.The modifications as described by the surgeon could be retraced in the evaluation of the post-op scan.The surgeon modified the implant on the indicated area.Due to different coordinate systems and slice thicknesses, the comparison between the post-op scan (2 mm slice thickness) to the design scan (1 mm) is limited.Yet, it can be assumed that the calcifications, which were highlighted in the design proposal to be removed prior to inserting the implant, partially still existed.In conclusion, the calcifications in the sphenoidal bone area not being fully removed likely caused the reported issue and would further explain the reported issue: ¿overlap of bone down by the two sides¿.The implant could be successfully modified during the procedure to fit as indicated and advised in the instruction for use.H3 other text : device is not available for return.

• 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
• MDR Report Key: 11325479
• Report Number: 0008010177-2021-00007
• Device Sequence Number: 883460
• Product Code: GWO
• UDI-Device Identifier: 07613327129274
• UDI-Public: 07613327129274
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 05/20/2021

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: 78-50040
• Device Catalogue Number: 78-50040
• Device Lot Number: 2101251010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 05/20/2021
• 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: Required Intervention