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 Codes	Unspecified Infection (1930); Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2020, it was reported that the accushape peek patient-specific cranial implant was explanted after the patient presented with an infection post-operatively.The cranial implant was used for treatment and not for diagnosis.On (b)(6) 2020, the initial reporter was contacted via email for additional information regarding the nature of the reported explant, including the date of explant and the patient's weight at the time of the event.Another request was made on august 14, 2020.No response was received to these requests.It could not be determined when the reported explant occurred, nor the weight of the patient at the time of the event.The device history record was reviewed.Production records did not indicate any nonconformance.The device in question was produced in accordance with all production requirements.Investigation did not identify any device problems.Investigation was unable to identify the cause of the reported infection.A follow-up report will be filed as appropriate if additional information becomes available.
Event or Problem Description
It was reported that the cranial implant was explanted after the patient presented with an infection post-operatively.

• Brand Name: ACCUSHAPE
• Common Device Name: PEEK PATIENT-SPECIFIC CRANIAL IMPLANT
• Manufacturer (Section D): MEDCAD; 501 south second ave; suite a1000; dallas, tx
• MDR Report Key: 10428436
• Report Number: 3009196021-2020-00009
• Device Sequence Number: 2828488
• Product Code: GXN
• UDI-Device Identifier: 00810007630120
• UDI-Public: (01)00810007630120(10)194308VIL
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2020

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
• Operator of Device: Health Professional
• Device Model Number: MC-SPK40
• Device Catalogue Number: MC-SPK40
• Device Lot Number: 194308VIL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 08/19/2020
• 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: Other
• Patient Age: 59 YR