MAUDE Adverse Event Report: DEPUY SYNTHES SPINE SKYLINE HYBRID THREE LEVEL PLATE,51MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 186803051

Device Problem Disassembly (1168)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

It was reported that when surgeon tried to unlock the skyline plate's locked cam, the cam mechanism popped out from the plate.Reports it was not broken but was completely out.The surgeon left out a screw at the level with no cam.

Manufacturer Narrative

A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device discarded by customer.

• Brand Name: SKYLINE HYBRID THREE LEVEL PLATE,51MM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; chemin blanc 38; le locle CH-2 400; SZ CH-2400
• Manufacturer Contact: anita barnick ; 325 paramount drive; raynham, MA 02767 ; 5088283583
• MDR Report Key: 4356027
• MDR Text Key: 5220502
• Report Number: 1526439-2014-12248
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK052552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 186803051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 11/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1