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

Catalog Number ACSL-003

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); No Information (3190)

Event Date 06/01/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Through internal review of historical cases, medcad discovered that approximately 15 months after providing an accushape patient-specific cranial implant (psci) for the patient, a second implant was provided for the same patient with the same defect, indicating that the previous accushape psci was explanted.

Manufacturer Narrative

According to the surgeon, the device was explanted approximately 7 months after it was implanted.The device in question was used for treatment and not for diagnosis.The device was implanted on (b)(6) 2017, however, the surgeon was unable to determine the exact date.Review of the device history record for the device found that the device was produced in accordance with medcad's production requirements.No nonconformance was identified during production.Communication with the surgeon on (b)(6) 2019, revealed that the device was explanted after the patient developed an infection.According to the surgeon, the infection was caused by the patient "picking" at the incision site.According to communication with the surgeon, the device was explanted on (b)(6) 2018, however the exact date could not be determined.The device was not returned for evaluation and the cause of the patient infection could not be verified.Medcad contacted the distributor sales representative via email on (b)(6) 2019, to request additional information from the surgeon, including the patient's weight at the time of the event.An additional follow-up phone call to obtain this information was made to the distributor sales representative on january 8, 2020.After multiple attempts, medcad was unable to obtain the patient's weight at the time of the event.

• Brand Name: ACCUSHAPE
• Type of Device: PEEK PATIENT-SPECIFIC CRANIAL IMPLANT
• Manufacturer (Section D): MEDCAD; 501 s. 2nd ave.; suite a1000; dallas TX 75226
• MDR Report Key: 9548880
• MDR Text Key: 173707946
• Report Number: 3009196021-2020-00002
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• PMA/PMN Number: K110684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

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 Catalogue Number: ACSL-003
• Device Lot Number: 172036 MAS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 01/03/2020
• Supplement Dates Manufacturer Received: 12/06/2019
• Supplement Dates FDA Received: 02/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR