MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK

Catalog Number UNKNOWN

Device Problem Difficult To Position (1467)

Patient Problem Nerve Damage (1979)

Event Date 06/19/2015

Event Type  Injury  

Event Description

Procedure/ technique: r-sided l4-s1 laminotomy/decompression it was reported that intra-op, during an l4-s1 r-sided discectomy, surgeon had difficulty sequentially dilating down to pathology using dilators.He then attempted to use a mallet and cobb in an effort to provide additional force dorsal to ventral and seat dilators on bony posterior skeletal anatomy.The additional force provided drove foreign objects through the lamina, severing the s1 nerve root and potentially fracturing the l5 vertebral body.An attempt at dural repair was performed and no further decompression was attempted.Patient complications were reported as unknown.

Manufacturer Narrative

(b)(4): neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.

• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4890451
• MDR Text Key: 21064936
• Report Number: 1030489-2015-01359
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• 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: 06/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other