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

Model Number MC-SPK20

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 06/08/2022

Event Type  malfunction  

Event Description

It was reported that the accushape peek patient-specific implant was modified to fit the patient's cranial defect.

Manufacturer Narrative

It was reported by distributor sales representative that the surgeon experienced difficulty fitting the accushape peek patient-specific implant to the patient's cranial defect.The complainant indicated that the orientation of the patient identification text on the implant did not appear to match the orientation of the text pictured within the case report.The surgeon reportedly had to modify the edges of the implant to help the device fit properly to the patient's defect.There was no patient harm indicated in the complaint report, however, the incident prolonged surgery by approximately 55 minutes.The manufacturing personnel responsible for producing the device stated that the text on the implant was oriented incorrectly due to an unintended error by the machine operator when placing the text onto the implant.

• 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: 14941179
• MDR Text Key: 295429313
• Report Number: 3009196021-2022-00007
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00810007630106
• UDI-Public: (01)00810007630106(10)226636MCC
• 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
• Report Date: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC-SPK20
• Device Catalogue Number: MC-SPK20
• Device Lot Number: 226636MCC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2022
• 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: 17 YR
• Patient Sex: Female
• Patient Weight: 47 KG