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

Model Number MC-SPK40

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

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

Event Date 12/30/2021

Event Type  malfunction  

Event Description

It was reported that the patient-specific cranial implant did not adequately fit the patient's cranial defect.Additional cranial mesh was required to complete the procedure.

Manufacturer Narrative

Investigation into the reported malfunction is ongoing.A follow-up report will be filed upon completion of the investigation.

Manufacturer Narrative

The complainant stated that the surgeon observed interference between the edge device and the patient's cranial bone.The surgeon reportedly modified the edge fit according to the instructions for use provided.After modifying the fit the surgeon used cranial mesh to cover the resulting gap and complete the procedure.There was no report of harm to the patient as a result of this event.A review of device history record found that the device was manufactured as designed and as requested by the surgeon.Upon examination of the patient's ct scan provided to medcad, there was evidence of image artifacts suggesting patient movement during the scan.Medcad's published ct scan instructions specify that motion artifacts must be avoided as they can negatively impact the functioning of final device.The device history record indicated that the ct scan provided as input to medcad was reviewed and approved; however, the patient movement was not initially detected.

• 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: 13366756
• MDR Text Key: 288318980
• Report Number: 3009196021-2022-00003
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00810007630120
• UDI-Public: (01)00810007630120(10)216439NOR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100684
• 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,Followup
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC-SPK40
• Device Catalogue Number: MC-SPK40
• Device Lot Number: 216439NOR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2021
• 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: 38 YR
• Patient Sex: Female