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

Model Number MC-SPK30

Device Problem Insufficient Information (3190)

Patient Problem Post Operative Wound Infection (2446)

Event Date 09/10/2022

Event Type  Injury  

Event Description

It was reported that an infection was detected and the left-sided peek cranial implant had to be removed.

Manufacturer Narrative

It was reported that the left-sided accushape peek patient-specific implant was explanted.The complainant requested another cranial implant of the same design and stated the patient experienced a wound infection.No additional surgical outcomes were reported at the time of the investigation.

• 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.; a1000; dallas TX 75226
• Manufacturer Contact: madeline bowie ; 501 south second ave/; suite a1000; dallas, TX 75226 ; 2142648864
• MDR Report Key: 15567095
• MDR Text Key: 301476131
• Report Number: 3009196021-2022-00008
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00810007630113
• UDI-Public: (01)00810007630113(10)227075MAG
• Combination Product (y/n): Y
• 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: 10/07/2022

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
• Device Operator: Health Professional
• Device Model Number: MC-SPK30
• Device Catalogue Number: MC-SPK30
• Device Lot Number: 227075MAG
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/07/2022
• Initial Date FDA Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2022
• 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: 74.9 YR
• Patient Sex: Male
• Patient Weight: 88 KG