MAUDE Adverse Event Report: SYNTHES BRANDYWINE PSI SD800.510 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Catalog Number SD800.510

Device Problem Fitting Problem (2183)

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

Event Date 02/10/2012

Event Type  malfunction  

Event Description

Sales consultant advised during a craniotomy procedure, the surgeon attempted to place a patient specific implant and the implant did not fit.The surgeon had to burr quite extensively to get the psi to fit.The implant was placed in the patient.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Synthes is submitting this report as a result of remediation activities.Blank fields on this form indicate the information is unknown, unavailable or unchanged.Device listed in this report is used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.A device history record review was conducted.The dhr review shows this device being manufactured and etched on 02/07/2012.On the following day, 02/08/2012, this device was inspected, ultrasonically cleaned and delivered to the (b)(4) plant.There were no nonconformance¿s noted for this device.Placeholder.

• Brand Name: PSI SD800.510 PEEK IMPLANT
• Type of Device: PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
• 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 ; 8006207025
• MDR Report Key: 4346717
• MDR Text Key: 5175738
• Report Number: 2530088-2014-00061
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• PMA/PMN Number: K033868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/10/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.510
• Device Lot Number: 6876129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2012
• Patient Sequence Number: 1
• Patient Outcome(s): Disability