MAUDE Adverse Event Report: SYNTHES BRANDYWINE PSI SD800.427 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Catalog Number SD800.427

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

Event Date 07/06/2012

Event Type  malfunction  

Event Description

It was reported that the product development department advised they received a notification from the field that a patient specific implant was too small for the patient's defect.It was also reported that the surgeon used titanium mesh in conjunction with the psi to complete the procedure.Report 1 of 1.

Manufacturer Narrative

Synthes is submitting this report as a result of remediation activities.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.The part in question was not returned for our evaluation.Based on the review of the verification models and the project file, the part fit as designed and as approved by the surgeon.Based on the review of the device history file for this device, it was determined that the records, including risk analysis, functional and design requirements, were present and acceptable.Based on these reviews, the design of this implant did not contribute to this complaint.If the part becomes available for evaluation this complaint will be re-open and updated.Placeholder.

• Brand Name: PSI SD800.427 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: 4346809
• MDR Text Key: 5200789
• Report Number: 2530088-2014-00068
• Device Sequence Number: 1
• Product Code: GXN
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/12/2012

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: Other
• Device Catalogue Number: SD800.427
• Device Lot Number: 6916087
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2012
• Patient Sequence Number: 1
• Treatment: PSI SD800.427 PEEK IMPLANT