MAUDE Adverse Event Report: SYNTHES (USA) 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 12/24/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient information was not provided by reporter.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 and was reportedly discarded by the reporting facility.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Mfr date: unknown.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 during an initial procedure on (b)(6) 2015 the synpor polyethylene portion of the implant peeled away from the titanium fan plate.The implant was not used.There were no fragments left in the patient and the surgery was successfully completed.There was a surgical time delay of ten minutes.The patient's post-operative status is unknown.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 (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5365216
• MDR Text Key: 36282078
• Report Number: 2520274-2016-10214
• Device Sequence Number: 1
• Product Code: GWO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK051879
• 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: 12/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08.520.221S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1