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

Model Number	78-10020
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	06/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Event or Problem Description
It was reported by hospital physician that a patient developed a post-surgical infection after a procedure with an implant.The procedure was reported as completed successfully.There are no additional details available at this time.
Event or Problem Description
It was reported by hospital physician that a patient developed a post-surgical infection after a procedure with an implant.The procedure was reported as completed successfully.There are no additional details available at this time.
Additional Manufacturer Narrative
The reported event could be confirmed, because the s.Aureus was found on microbiological analysis from the wound taken during the revision surgery.Additionally, the device was not returned as anticipated.To gain more information about the complained event, the ¿infection complaints ¿ checklist customer¿ (cmfqf 13-003) and further questions were forwarded to the sales rep.In the provided answers it was stated that the initial surgery took place in (b)(6) 2020 and the infection was discovered in (b)(6) 2020.Due to neurological impairment, the patient could not understand instructions, but the patient has been very carefully observed at the ward during the whole time between the initial surgery and the revision.Additionally, the ¿infection complaints - checklist investigator¿ (b)(4) was completed by the manufacturing site for the affected device.For infection complaints, expanded investigations are performed to assure that neither the reported device nor all related manufacturing (e.G.Environmental monitoring, sterilization validations tests) process steps could have caused the event.The reported device is delivered non-sterile and the sterilization parameters indicated in the corresponding instruction for use are validated.Indications for any device or manufacturing related problems were not found.After a follow up call with the sales rep and a stryker associate clinical research manager among others, related literature e.G.The ¿infection following insertion of implants¿ position paper as far as further related papers were provided.They describe the aspects of a possible postoperative complication as the occurrence of inflammations of or around the inserted implant.In general, infections, foreign body reactions and inflammations following the insertion of implants are well known adverse events associated with these procedures.They are well documented in the instruction for use and have been considered in the risk evaluation of the relevant stryker product.Overall, the benefits of this product to the patient was found to outweigh the possible occurrence of inflammations.Therefore, inflammations at implant sites are considered a risk which is induced by the procedure but does not exceed the benefits involved.Based on statistical evaluation 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 deemed necessary at this time.The complaint is added to the complaint trend.Should further information be available, the investigation will be re-evaluated.H3 other text : device was not received.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT KIT, M
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 10155500
• Report Number: 0008010177-2020-00030
• Device Sequence Number: 17110527
• Product Code: GWO
• UDI-Device Identifier: 07613327004021
• UDI-Public: 07613327004021
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• PMA/510(K) Number: K121153
• 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): 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 78-10020
• Device Catalogue Number: 78-10020
• Device Lot Number: 2003031004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 04/13/2021
• 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