MAUDE Adverse Event Report: MSD DEGGENDORF MFG CORNERSTONE-SR CAGE SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

Catalog Number 6272416

Device Problem Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 06/03/2014

Event Type  Injury  

Event Description

It was reported that a patient underwent an anterior cervical fusion at c4-c5.Displacement of the cage occurred.A revision surgery was performed.No fragments of the device remaining in the patient.

Manufacturer Narrative

(b)(4): neither the device nor applicable imaging films were returned to the manufacturer for evaluation; therefore, the cause of the event cannot be determined.

• Brand Name: CORNERSTONE-SR CAGE SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 3909080
• MDR Text Key: 15104700
• Report Number: 1030489-2014-03005
• Device Sequence Number: 1
• Product Code: ODP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6272416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2014
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 00062 YR