MAUDE Adverse Event Report: OSSDSIGN OSSDSIGN CRANIAL PSI; CRANIOPLASTY PLATE

Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation into the malfunction found that the fixation point was placed too close to the building block in the 3d print causing a mechanical deficiency in one fixation arm when the support material was manually removed.During the investigation it was also discovered that the orientation of the titanium mesh, in relation to the building block, could have introduced further mechanical deficiencies in the given fixation arm as the support structure added to maintain it mechanical stability did not fully fulfil its intended use.This resulted in a fixation arm breakage during shipment of the device.The mechanical properties of the implanted device have been reviewed and found sufficient for its intended use.The remaining 5 fixation arms are not affected by the deficiency and sufficient to maintain the implant's position.The found manufacturing deficiencies have been addressed.
Event or Problem Description
It was reported that the patient specific implant arrived at the or with a fixation arm broken off.The fixation arm was contained within its protective silicon sleeve and the double sterile packaging remained intact.Surgeon decided to use the implant and proceeded to trim away the piece of the remaining fixation arm.During the trimming a small fracture was introduced on an adjacent ceramic tile due to the applied force.The fit of the implant was deemed as good and the remaining 5 fixation arms were used to fixate the implant to the cranium. otherwise the surgery was uneventful and no complications have been reported so far in regard to patient outcome.

• Brand Name: OSSDSIGN CRANIAL PSI
• Common Device Name: CRANIOPLASTY PLATE
• Manufacturer (Section D): OSSDSIGN; virdings allé 2; uppsala,
• MDR Report Key: 8179301
• Report Number: 3013282271-2018-00001
• Device Sequence Number: 16661583
• Product Code: GXN
• UDI-Device Identifier: 07350086550115
• UDI-Public: (01)07350086550115
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 06/21/2018
• Report Date (Section F): 06/08/2018

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 Expiration Date: 05/25/2019
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/08/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR