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

Model Number ACSX-004

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intracranial Hemorrhage (1891)

Event Date 10/11/2020

Event Type  Injury  

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 Description

It was reported that the peek cranial implant was explanted to treat the patient for an epidural hematoma.

• Brand Name: ACCUSHAPE
• Type of Device: PEEK PATIENT-SPECIFIC CRANIAL IMPLANT
• Manufacturer (Section D): MEDCAD; 501 south second ave; suite a1000; dallas TX 75226
• Manufacturer (Section G): MEDCAD; 501 south second ave; suite a1000; dallas TX 75226
• Manufacturer Contact: james allo ; 501 south second ave; suite a1000; dallas, TX 75226 ; 2144538864
• MDR Report Key: 10796252
• MDR Text Key: 215110117
• Report Number: 3009196021-2020-00013
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00810007630076
• UDI-Public: (01)00810007630076(10)205071MCD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ACSX-004
• Device Catalogue Number: ACSX-004
• Device Lot Number: 205071MCD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR
• Patient Weight: 65