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

Model Number MC-SPK30

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/27/2023

Event Type  malfunction  

Manufacturer Narrative

Complainant reported that there was visible cerebral swelling preventing the implant from fitting the patient.Complainant reported that the cerebral swelling was too pronounced to complete the surgery.

Event Description

Patient-specific peek cranial implant could not be implanted due to fit issue.Fit issue was caused by noticeable cerebral/soft tissue swelling.

• Brand Name: ACCUSHAPE
• Type of Device: PEEK PATIENT SPECIFIC CRANIAL IMPLANT
• Manufacturer (Section D): MEDCAD; 501 s second ave; suite a1000; dallas TX 75226
• Manufacturer (Section G): MEDCAD; 501 s second ave; suite a-1000; dallas TX 75226
• Manufacturer Contact: madeline bowie ; 501 s second ave; suite a-1000; dallas, TX 75226 ; 2144538864
• MDR Report Key: 18566683
• MDR Text Key: 333515095
• Report Number: 3009196021-2024-00001
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00810007630113
• UDI-Public: (01)00810007630113(10)239175KIN
• 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: Other
• Type of Report: Initial
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MC-SPK30
• Device Catalogue Number: MC-SPK30
• Device Lot Number: 239175 KIN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2023
• 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 Age: 72 YR
• Patient Sex: Female