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

Model Number MC-SPK40

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient presented post-operatively with an unspecified infection and would require explantation of the cranial implant.

Event Description

It was reported that the patient presented post-operatively with an unspecified infection and would require explantation of the cranial implant.

Manufacturer Narrative

On (b)(6) 2021 medcad contacted the initial reporter via email to request additional information about the reported event.The information requested included the nature of the infection the patient reportedly experienced, any potential causes, and the date of the device explant.The initial reporter was contacted by phone on (b)(6) 2021 as a follow-up to the previous email.On (b)(6) 2021, medcad made a third attempt to contact the initial reporter, again via email.No response was received to medcad's requests for additional information.On (b)(6) 2021 medcad completed a review of the device history record for the suspect device.Investigation into the device history record found no evidence of nonconformance with any established production process.No device problem was identified.The investigation did not establish a cause for the reported infection.

• 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: 12674708
• MDR Text Key: 277711957
• Report Number: 3009196021-2021-00006
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00810007630120
• UDI-Public: (01)00810007630120(10)215818ZOL
• 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,Followup
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MC-SPK40
• Device Catalogue Number: MC-SPK40
• Device Lot Number: 215818ZOL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• 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: 24 YR
• Patient Sex: Male
• Patient Weight: 67 KG