MAUDE Adverse Event Report: SYNTHES BRANDYWINE PSI SD800.519 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Catalog Number SD800.519

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient initials are (b)(6).Patient weight was not provided by reporter.The patient specific implant was implanted; however, the complaint portion of the implant, the orbit, was not implanted.The complaint portion subject device is not expected to be returned to the synthes manufacturer for evaluation.The remainder of the subject device has been implanted in the patient.A device history record review was performed for the subject device.Documentation shows this device was manufactured and laser marked on 07 dec 2015 by the tech center prototype shop as per model specifications supplied by cmf product development.This device was then transported to the brandywine manufacturing plant for the following operations: inspection, dry ice blast, ultra sonic cleaning and plasma treatment which were completed on (b)(6) 2015.No inconsistencies were found during these processes.There were no non-conformances issued against this work order.Date of release to warehouse was (b)(4) 2015.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 the surgeon indicated that he was not happy with the orbital floor of a patient specific implant that was implanted in an orbital reconstruction case on (b)(6) 2015.The orbit portion of the implant was not used.The surgeon felt that the patient's reconstruction is suboptimal as a result.The surgeon did his best using additional materials to reconstruct the orbit and he was not pleased with the final outcome.This report is 1 of 1 for (b)(4).

• Brand Name: PSI SD800.519 PEEK 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5357394
• MDR Text Key: 35557936
• Report Number: 2530088-2016-10004
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK053199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.519
• Device Lot Number: 53347134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28 YR