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

Catalog Number ACSL-003

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Injury (2348)

Event Date 07/19/2018

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment and not for diagnosis.On (b)(6) 2018, a sales representative informed medcad that during surgery, it was determined that the accushape peek patient-specific cranial implant did not fit the patient as intended.Review of production records for this case determined that, upon request of the surgeon, the patient-specific implant was designed and manufactured using ct data that was greater than 3 months old.Surgery was completed without implanting the device, and a second accushape peek patient-specific cranial implant was requested.A second ct scan, dated (b)(6) 2018, was sent with the request for a new implant.The new accushape implant was manufactured and distributed on august 6, 2018.During a telephone conversation on (b)(6) 2018, the complainant reported that the patient was in fair condition.The complainant was unable to confirm what had been done with the original implant.The complainant was unable to confirm the patient's weight.If additional information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

On (b)(6) 2018, a sales representative notified medcad that the accushape peek patient-specific cranial implant did not fit the patient as intended.During the surgery, it was determined that the implant would not adequately fit the patient's defect.Surgery was completed without implanting the device, and a second accushape patient-specific implant was requested.

• Brand Name: ACCUSHAPE
• Type of Device: PEEK PATIENT-SPECIFIC IMPLANT
• Manufacturer (Section D): MEDCAD; 501 s. 2nd ave.; suite a1000; dallas TX 75226
• Manufacturer (Section G): MEDCAD; 501 s. 2nd ave.; suite a1000; dallas TX 75226
• Manufacturer Contact: estelle anuwe ; 501 s. 2nd ave.; suite a1000; dallas, TX 75226 ; 2144538864
• MDR Report Key: 8737698
• MDR Text Key: 149334328
• Report Number: 3009196021-2019-00006
• Device Sequence Number: 1
• Product Code: GXN
• 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: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• 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: 182624 BRO
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2018
• 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: 36 YR