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

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2018

Event Type  malfunction  

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 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
• Type of Device: CRANIOPLASTY PLATE
• Manufacturer (Section D): OSSDSIGN; virdings allé 2; uppsala,
• Manufacturer (Section G): OSSDSIGN; virdings allé 2; uppsala,
• Manufacturer Contact: ulrik birgersson ; virdings allé 2; uppsala,
• MDR Report Key: 8179301
• MDR Text Key: 131798154
• Report Number: 3013282271-2018-00001
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 07350086550115
• UDI-Public: (01)07350086550115
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 06/08/2018,06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2018
• 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 Age: 26 YR