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

Model Number	MC-SPK20
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that the anterior cranial implant did not fit the defect as expected.Adjustment to the anterior implant also required an adjustment to the posterior implant for an acceptable fit during surgery.It was reported that the surgery was successful utilizing the modified implant.It was also noted that the reported error did not prolong the surgery or affect the surgical outcome in any other way.A review of the production records found that the device was manufactured as designed and approved by the surgeon and met all specifications during the quality inspection.Further investigation revealed a "possible resection" highlighted in the surgeon-approved case report; however, the complainant was not able to confirm whether or not the resection was completed by the surgeon during surgery.Additionally, the case designer stated that resecting the bone highlighted in the case report was crucial for a good fit.Given the investigation findings, a clear cause of the reported error could not be established.The complainant was not able to provide information such as the patient's weight when requested.
Event or Problem Description
The anterior cranial implant did not fit as expected.As a result, the anterior and posterior implants had to be modified to allow for an acceptable fit.

• Brand Name: ACCUSHAPE
• Common Device Name: 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: 17311203
• Report Number: 3009196021-2023-00004
• Device Sequence Number: 6684691
• Product Code: GXN
• UDI-Device Identifier: 00810007630106
• UDI-Public: (01)00810007630106(10)238282MAT
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 07/11/2023

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: 238282 MAT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2023
• 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: 54 YR
• Patient Sex: Female