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

Model Number	SD420.433
Medical Device Problem Code	Material Distortion (2977)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/01/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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).
Additional 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
• Common Device Name: PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• MDR Report Key: 6677371
• Report Number: 2530088-2017-10212
• Device Sequence Number: 13923820
• Product Code: GXN
• UDI-Device Identifier: 10887587069890
• UDI-Public: (01)10887587069890(10)H290803
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K033868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2017

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?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 06/01/2017
• Supplement Date Received by Manufacturer: 07/05/2017
• Initial Report FDA Received Date: 06/29/2017
• Supplement Report FDA Received Date: 07/14/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention