MAUDE Adverse Event Report: SYNTHES MONUMENT SYNPOR SMOOTH TI REINFORCED FAN PL FIXTN H/0.8MM THK-STER; PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE

Catalog Number 08.520.221S

Device Problem Peeled/Delaminated (1454)

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

Event Date 08/02/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).Additional device product codes are ftl and ftm.(b)(4).The subject device is not expected to be returned to the synthes manufacturer for evaluation.A device history record review was performed for the subject device lot.Manufacturing location: (b)(4); supplier: (b)(4).Product manufacture date/release to warehouse date: dec 11, 2015.Product expiration date: oct 28, 2020.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 polyethylene coating on a fan plate peeled away from the titanium during a right orbital floor open reduction internal fixation (orif) on (b)(6) 2016.As the surgeon cut the synpor smooth titanium (ti) reinforced fan plate to shape it, a portion of the porous polyethylene peeled away from the titanium.The remaining portion of the polyethylene was still attached so the surgeon decided to use the plate.There was no reported surgical delay.The procedure was completed with no patient harm.This report is 1 of 1 for (b)(4).

• Brand Name: SYNPOR SMOOTH TI REINFORCED FAN PL FIXTN H/0.8MM THK-STER
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5880704
• MDR Text Key: 52275942
• Report Number: 1719045-2016-10615
• Device Sequence Number: 1
• Product Code: GWO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051879
• 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: 08/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2020
• Device Catalogue Number: 08.520.221S
• Device Lot Number: DSD0927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 50 YR