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

Model Number MC-SPK40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Type  Injury  

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 Description

It was reported that the cranial implant was explanted after the patient presented with an infection post-operatively.

• Brand Name: ACCUSHAPE
• Type of Device: PEEK PATIENT-SPECIFIC CRANIAL IMPLANT
• Manufacturer (Section D): MEDCAD; 501 south second ave; suite a1000; dallas, tx
• Manufacturer (Section G): MEDCAD; 501 south second ave; suite a1000; dallas, tx
• Manufacturer Contact: james allo ; 501 south second ave; suite a1000; dallas, tx ; 4538864
• MDR Report Key: 10428436
• MDR Text Key: 203668628
• Report Number: 3009196021-2020-00009
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00810007630120
• UDI-Public: (01)00810007630120(10)194308VIL
• 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: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MC-SPK40
• Device Catalogue Number: MC-SPK40
• Device Lot Number: 194308VIL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2020
• 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): Other
• Patient Age: 59 YR