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

Model Number	MC-SPK40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation into the event is ongoing.A follow-up will be filed upon completion of the investigation.
Event or Problem Description
The patient specific cranial implant was reportedly explanted after the patient presented an infection post-operatively.
Additional Manufacturer Narrative
On may 26, 2021, medcad was informed by complainant via telephone call about the accushape peek cranial implant being reportedly explanted after the patient presented an infection post-operatively.The patient-specific cranial implant was used for treatment and not diagnosis.The weight of the patient was not provided by the complainant in the initial report.A response to the surgeon responsible for this case was sent in the form of a letter on june 29, 2021.The response included an attempt to retrieve more information surrounding the event including the weight of the patient at the time of the surgery.An additional contact attempt to receive more information for this event was made on july 09, 2021.Both attempts to retrieve this information have been met with no response.The device history record for this case was reviewed to determine whether any nonconformances related to the production of the device in question may have contributed to the patient infection.The inspection records for the device showed passing results against device specifications approved by the surgeon responsible for this case.Investigation of the production records found no nonconformances that may have contributed to the patient infection and indicated that the device in question was produced according to medcad standards.The investigation for this case found no direct cause for the patient infection.If additional information is provided to medcad, an additional follow up report will be submitted.

• Brand Name: ACCUSHAPE
• Common Device Name: PEEK PATIENT-SPECIFIC CRANIAL IMPLANT
• Manufacturer (Section D): MEDCAD; 501 south second ave; suite a1000; dallas TX 75226
• MDR Report Key: 12071964
• Report Number: 3009196021-2021-00005
• Device Sequence Number: 14640684
• Product Code: GXN
• UDI-Device Identifier: 00810007630120
• UDI-Public: (01)00810007630120(10)215535RAM
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K110684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

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
• Operator of Device: Health Professional
• Device Model Number: MC-SPK40
• Device Catalogue Number: MC-SPK40
• Device Lot Number: 215535 RAM
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR