MAUDE Adverse Event Report: DEPUY SYNTHES SPINE LUMBAR WEDGED I/F CAGE(7X9)X9X21; SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM

Catalog Number 173121207

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2014

Event Type  malfunction  

Event Description

International affiliate reports the lumbar wedged i/f cage was broken during surgery.The cage was placed at l4/5.Since the position of the cage was not appropriate, the surgeon was adjusting the cage position with the inserter still attached to the cage in disk space.Then, it was noted that the cage was broken.No broken piece was left in the patient's body.The procedure was delayed by ten minutes and there were no adverse consequences to the patient.

Manufacturer Narrative

A follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Visual verification of the returned lumbar wedged i/f cage confirmed that the cage had been fractured along the whole length of the threaded hole.A review of the device history record found no discrepancies.The lot was released accomplishing all quality requirements.A 12-month review of the complaint trend analysis for the product code noted that there were no other complaints for issues associated with the cage breakage during surgery.The root cause of the cage becoming broken during surgery 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 (capa) is necessary at this time as there have been no issues identified in the manufacturing or release of this cage that could have contributed to the problem reported by the customer.Therefore, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LUMBAR WEDGED I/F CAGE(7X9)X9X21
• 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: 3899218
• MDR Text Key: 14875967
• Report Number: 1526439-2014-11637
• Device Sequence Number: 1
• Product Code: MCV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP960025 008
• 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: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 173121207
• Device Lot Number: 5L89B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 07/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2013
• 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