MAUDE Adverse Event Report: MEDCAD ACCUSHAPE; PEEK PATIENT-SPECIFIC CRANIAL IMPLANT

Model Number	ACSX-004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	10/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On october 14, 2020 it was reported that the accushape peek patient-specific cranial implant was explanted.A surgical nurse who was present at the time of the reported event was contacted by telephone on november 04, 2020.According to this communication, the device in question was reportedly explanted on (b)(6) 2020 after the patient experienced an epidural hematoma.The patient reportedly had "a lot of issues" including a "severely damaged brain" from preexisting health conditions.According to the nurse, the patient had undergone a previous decompressive craniectomy, tracheostomy, and had also previously experienced a ruptured brain aneurism before the device in question was implanted.In the nurse's opinion, the epidural hematoma experienced by the patient was "definitely not from the implant." analysis of production records for the device in question found that the materials and processes used to produce the device in question were in conformance with production requirements.Records contained within the device history record showed that the device in question satisfied all required in-process inspection criteria.Investigation did not identify any device problems.Production records showed that medcad provided a replacement peek patient-specific implant for the patient on (b)(6) 2020.According to communication with the surgical nurse, the replacement cranial implant was implanted on (b)(6) 2020 without incident.The cause of the reported epidural hematoma could not be established.
Event or Problem Description
It was reported that the peek cranial implant was explanted to treat the patient for an epidural hematoma.

• Brand Name: ACCUSHAPE
• Common Device Name: PEEK PATIENT-SPECIFIC CRANIAL IMPLANT
• Manufacturer (Section D): MEDCAD; 501 south second ave; suite a1000; dallas TX 75226
• MDR Report Key: 10796252
• Report Number: 3009196021-2020-00013
• Device Sequence Number: 19552020
• Product Code: GXN
• UDI-Device Identifier: 00810007630076
• UDI-Public: (01)00810007630076(10)205071MCD
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K110684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2020

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: ACSX-004
• Device Catalogue Number: ACSX-004
• Device Lot Number: 205071MCD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 11/05/2020
• 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
• Patient Age: 27 YR
• Patient Weight: 65