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

Model Number	MC-SPK20
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the accushape peek patient-specific implant was modified to fit the patient's cranial defect.
Additional 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
• Common Device Name: 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
• Report Number: 3009196021-2022-00007
• Device Sequence Number: 17334234
• Product Code: GXN
• UDI-Device Identifier: 00810007630106
• UDI-Public: (01)00810007630106(10)226636MCC
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K110684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MC-SPK20
• Device Catalogue Number: MC-SPK20
• Device Lot Number: 226636MCC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Weight: 47 KG