MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG MEDPOR CUSTOMIZED CRANIAL-L; IMPLANT

Model Number	5444-0-310
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Cerebral Edema (4403); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/29/2021
Type of Reportable Event	Serious Injury
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 patient had a bump near where his glasses sit.The surgeon had a ct scan done that showed the rigid fixation coming off of the bone.There was medical intervention requiring a revision surgery.
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 patient had a bump near where his glasses sit.The surgeon had a ct scan done that showed the rigid fixation coming off of the bone.There was medical intervention requiring a revision surgery.
Additional Manufacturer Narrative
The complaint event could be confirmed based on the ct scans provided to design the new peek implant.The complaint department has already covered three previous reported events with medpor customized products lot# 2007161015 and lot#: 2011091030 with this patient under pi#: (b)(6).According to the previous investigations the patient had back-to-back issues with brain swelling.The surgeon used an external ventricular drain (evd) to drain extra cerebrospinal fluid (csf) from the brain.After loosening of the implant (lot#: 2011091030) in a previous reported event covered under pi#: (b)(6).The same complications occurred in the area where the swelling is present laterally and posteriorly to the patient¿s left eye.After this happened the surgeon decided to design a new implant again and switch to a customized peek implant from stryker (lot#: 2109161009).With the scans provided to design the peek implant, it could be confirmed that even though the implant was fixated appropriately, with more screws and plates than recommended, the implant loosened due to the pressure of the brain fluid in the area where the swelling of the patient is present.Furthermore, a review of the manufacturing records for medpor customized cranial-l (54440310), lot: 2011091030 was conducted.Final release test data confirmed the lot meets all final release specifications.Summarizing all obtained information, the root cause of the reported event that the fixation is pulling out from patient¿s bone was caused by the swelling present laterally and posteriorly to the patient¿s left eye prior to the implant.Additionally, it is the surgeon¿s responsibility to reduce the swelling prior to implanting the device.Based on the information provided, the statistical evaluation, the device history review and the complaint analysis by stryker¿s customized implants designer there is no indication for any systematic, material or manufacturing related issue.H3 other text: device not made available by customer.
Event or Problem Description
It was reported that the patient had a bump near where his glasses sit.The surgeon had a ct scan done that showed the rigid fixation coming off of the bone.There was medical intervention requiring a revision surgery.

• Brand Name: MEDPOR CUSTOMIZED CRANIAL-L
• 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: 13052593
• Report Number: 0008010177-2021-00057
• Device Sequence Number: 19871965
• Product Code: FWP
• UDI-Device Identifier: 07613252457640
• UDI-Public: 07613252457640
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143173
• 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): 03/24/2022

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
• Device Model Number: 5444-0-310
• Device Catalogue Number: 54440310
• Device Lot Number: 2011091030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2021
• Supplement Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown