MAUDE Adverse Event Report: DEPUY SYNTHES SPINE JAGUAR LUMBAR WEDGED I/F CAGE; SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM

Catalog Number 173123209

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2014

Event Type  malfunction  

Event Description

It was reported that the physician found it difficult to the cage into the vertebral body, and so the cage with inserter was moved cephalocaudal.The cage broke cleanly into two pieces with one piece remaining on the inserter, and the other at the vertebral body.The pieces were removed and fit together perfectly, so the physician reports no fine fragments were lost within the patient.Another product was used to complete the case with a 20 minutes delay to the surgery time.No adverse patient consequences to the patient were reported.

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Manufacturer Narrative

Visual inspection noted that the cage had been broken into 2 solid segments.A review of the device history record for the lumbar cage found no discrepancies during the manufacturing of the product.No issues were identified during the manufacturing and release of this product that could have been contributed to the problem reported by the customer.The product was released accompanying all quality requirements.A 12-month review of the complaint trend analysis for the lumbar cage was conducted on the specific product code from this complaint as the height of the implant affects the stress profile on insertion and therefore this height is not indicative of the family or vice versa.It was noted that there were no related complaints for issues of this nature.The root cause of the lumbar cage breakage cannot positively be determined.However, as noted in the accompanying instructions for use, excessive torque, when applied to long-handle insertion tools, can cause splitting or fracture of the polymer/carbon-fiber implants.When a polymer/carbon-fiber implant is impacted or hammered into place, the broad surface of the insertion tool should be carefully seated fully against the implant.Impaction forces applied directly to a small surface of the implant could cause fracture of the implant.No corrective action/preventive action is required as there has been no issue identified in the manufacturing or release of this device, and there have been no systematic trends.Therefore, this complaint will be closed with no further action required.

• Brand Name: JAGUAR LUMBAR WEDGED I/F CAGE
• Type of Device: SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: anita barnick ; 325 paramount drive; raynham, MA 02767 ; 5088283583
• MDR Report Key: 3596462
• MDR Text Key: 4068404
• Report Number: 1526439-2014-11229
• Device Sequence Number: 1
• Product Code: MCV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP960025/S8
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 173123209
• Device Lot Number: K5609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2014
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/07/2014
• Event Location: Hospital
• Date Manufacturer Received: 01/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2009
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1