MAUDE Adverse Event Report: SYNTHES BRANDYWINE PSI SD420.433 TITANIUM IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Model Number SD420.433

Device Problem Material Distortion (2977)

Patient Problem No Code Available (3191)

Event Date 06/01/2017

Event Type  Injury  

Manufacturer Narrative

Patient age, dob & weight not provided for reporting.Device malfunctioned intra-operatively and was not implanted / explanted (b)(4).The surgeon attempted to modify the plate; however, had to use titanium mesh instead.There was a 45 minute delay in surgery.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that the: part #: sd420.433 / lot #: h290803.Manufacture site: (b)(4).Manufacture date: 16-feb-2017.No ncrs or scrap were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint action.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that a patient specific implant (psi), a synthes titanium cranial implant, did not fit properly during an initial cranioplasty procedure on (b)(6) 2017.During the procedure, the surgeon attempted to modify the plate; however, was forced to use titanium mesh instead.There was a 45 minute delay in surgery while the surgeon attempted to modify the implant.The surgery was successfully completed and the patient was reported as stable.This complaint involves one (1) device: titanium cranial implant, with one part data.This report is 1 of 1 for com-(b)(4).

Manufacturer Narrative

Manufacturing evaluation was completed.Device sd420.433 (h290803) was received for evaluation.The receive device had been cut into 4 pieces.This damage was done post manufacturing.The received device was compared with the functional check device (model).A visual comparison of the returned device sd420.433 (h290803) to the image on the psi router was completed.The larger section of the returned device was used to compare to the image on psi router.They appear very similar.A final check was made by reprinting the functional device (fcd) for sd420.433 (h290803) and matching it to the returned device.They both match well with each other.Implant raw material was evaluated.The larger section of the returned device was analyzed utilizing a niton gun over at the brw plant.It verifies the results that the implant¿s material is titanium.The complaint was determined to be unconfirmed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PSI SD420.433 TITANIUM IMPLANT
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6677371
• MDR Text Key: 78718791
• Report Number: 2530088-2017-10212
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 10887587069890
• UDI-Public: (01)10887587069890(10)H290803
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SD420.433
• Device Catalogue Number: SD420.433
• Device Lot Number: H290803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention