MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number 2982001

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/14/2019

Event Type  malfunction  

Manufacturer Narrative

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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent direct lateral interbody fusion at l4-l5 due to stenosis and spondylolisthesis.Intra-op, the instrument broke.The product came in contact with the patient.No fragment of the broken product remained inside the patient.There were no patient complications as a result of this event.

Manufacturer Narrative

Product analysis: visual examination confirmed the upper and lower tang/prong of the threaded inserter have broken off; the broken pieces are missing and not returned for analysis.Fracture initiation appears to be located at the base of the tang, consistent with bend stress overload.Optical examination of the fracture surface reveals a fracture, with no indication of fatigue, and a sheer lip which suggests the direction of fracture.The above observations are consistent with bend stress overload.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8324796
• MDR Text Key: 135676157
• Report Number: 1030489-2019-00128
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 00885074549736
• UDI-Public: 00885074549736
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2982001
• Device Lot Number: PR11L012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2019
• Initial Date FDA Received: 02/11/2019
• Supplement Dates Manufacturer Received: 03/12/2019
• Supplement Dates FDA Received: 03/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2013
• 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 Age: 61 YR