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

Model Number MC-SPK30

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Three attempts were made via email to obtain additional information; however, the complainant was not able to provide information such as patient weight and date of event.

Event Description

Patient presented a post-operative infection.

• 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 a1000; dallas TX 75226
• Manufacturer Contact: madeline bowie ; 501 s second ave; suite a1000; dallas, TX 75226 ; 2144538864
• MDR Report Key: 16675353
• MDR Text Key: 312628624
• Report Number: 3009196021-2023-00001
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00810007630113
• UDI-Public: (01)00810007630113(10)227228MAG
• 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: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• 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: 227228 MAG
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male