MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC THREADED INSERTER; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number 2980001

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2014

Event Type  malfunction  

Event Description

It was reported that the implant was difficult to be removed from the inserter after it was placed in the disk space during an unspecified spinal surgery.There were no reports of patient complications.

Manufacturer Narrative

(b)(4): analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.

Manufacturer Narrative

Additional information: the device has been returned to the manufacturer for evaluation.The inserter was retuned with the inner shaft not installed correctly into the thumbwheel, the shaft was not seated deep enough.Once disassembled and reassembled correctly the instrument functioned properly.There was a witness mark on the inner shaft to indicate the shaft had been in place at one time.

• Brand Name: THREADED INSERTER
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• 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: 3666720
• MDR Text Key: 4342894
• Report Number: 1030489-2014-01796
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K073291
• 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,Followup
• Report Date: 04/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2980001
• Device Catalogue Number: 2980001
• Device Lot Number: PR11G003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1