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

Model Number	78-50030
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Cerebral Edema (4403); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
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 during the procedure the implant was not fitting as expected and it was noticed that the patient had swelling of the brain.The cerebrospinal fluid was drained and in addition to this, the surgeon cut and adjusted the implant to fit correctly.No other information is known at this time.
Event or Problem Description
It was reported that during the procedure the implant was not fitting as expected and it was noticed that the patient had swelling of the brain.The cerebrospinal fluid was drained and in addition to this, the surgeon cut and adjusted the implant to fit correctly.No other information is known at this time.
Additional Manufacturer Narrative
The reported event ¿difficulty finding the correct fit [of] the implant¿ could be confirmed, as intra-operative images that showed the issue were provided.According to the sales representative, the implant was ¿cut and adjusted to fit¿.It was described that the implant was cut ¿between the last three dura suture holes and the row of holes above it¿.The surgeon used mesh in the region the implant was cut off.Two aspects regarding the reported issue were noted by the sales representative: first, ¿patient¿s brain did have quite a bit of swelling [¿] swelling was very existing during the case¿.Second, although swelling was very existent during the case, per statement of the sales representative, the surgeon believed that the implant was ¿physically different than what she saw in the design proposal¿ and ¿flanged up and away from the native bone¿.A medical expert was consulted, and he stated that ¿swelling would be much reduced after 4 weeks¿.From the provided images, the medical expert stated that ¿swelling appears minimal¿ and ¿did not affect the fit¿.The analysis performed by the peek cci design team showed that ¿the implant design and all quality relevant design steps were performed in accordance to [our] procedures.The implant is designed as it got requested by the surgeon¿.Further, during manufacturing, a 100%-dimensional inspection was performed through structured light scanning and passed.Additionally, the analysis of the cci design team states that additionally a fracture line through part of the posterior temporal and inferior parietal bone was present in the skull.It is not clear whether this has changed since the scan was acquired.The surgeon¿s belief that the implant was different from what was displayed in the design proposal could not be confirmed, as the implant was designed and manufactured according to specification.Yet, the reported issue (¿difficulty finding the correct fit¿) could be confirmed from the images provided.Possible root causes, that were identified, are the fracture line and the presence of swelling during surgery.However, this was not confirmed by the medical expert¿s assessment.Therefore, a distinct root cause remains uncertain.H3 other text: device not available for return.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT PRIORITY, L
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 11741249
• Report Number: 0008010177-2021-00023
• Device Sequence Number: 11569101
• Product Code: GWO
• UDI-Device Identifier: 07613327129267
• UDI-Public: 07613327129267
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K152076
• 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): 08/04/2021

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: 78-50030
• Device Catalogue Number: 78-50030
• Device Lot Number: 2103121029
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 08/04/2021
• 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