MAUDE Adverse Event Report: SYNTHES BRANDYWINE PSI SD800.534 PEEK IMPLANT; PLATE CRANIOPLASTY PREFORMED NONALTERABLE

Catalog Number SD800.534

Device Problems Difficult To Position (1467); Inadequacy of Device Shape and/or Size (1583)

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

Event Date 04/19/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is not expected to be returned for manufacturer review/investigation.Device history records was conducted.The report indicates that the: manufacturing location: (b)(4) facility, sd800.534 lot h075757, manufacturing date: 6-apr-2016.No ncrs were generated during production.Review of the device history records showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.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) did not fit correctly.This was identified during a planned cranioplasty procedure on (b)(6) 2016.The contour of the psi was not correct for fitting the temporal/parietal lobes.The psi was modified and additional titanium mesh implants were used to correct the deformity.There was a reported approximate 45 minute surgical delay.The procedure was completed with satisfactory anatomic result and with the patient in stable condition.This complaint involves one device.This report is 1 of 1 for (b)(4).

• Brand Name: PSI SD800.534 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 ; 6107195000
• MDR Report Key: 5634300
• MDR Text Key: 44499568
• Report Number: 2530088-2016-10126
• 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: Other
• Type of Report: Initial
• Report Date: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.534
• Device Lot Number: H075757
• Other Device ID Number: (01)10887587065939(10)H075757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1