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 10/29/2018

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 presented with stenosis; and underwent oblique lumbar interbody fusion.Intra-op, the distal tip of the inserter broke during cage insertion.The product came in contact with the patient.No fragment of the broken instrument remained in the patient.No patient complications were reported as a result of this event.

Manufacturer Narrative

Visual examination confirmed the upper tang/prong of the threaded inserter has broken off; the broken piece is 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 fairly quasi-brittle fracture, with no indication of fatigue, and a shear 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: 8099748
• MDR Text Key: 128197811
• Report Number: 1030489-2018-01527
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

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: PR11C019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 11/23/2018
• Supplement Dates Manufacturer Received: 01/23/2019
• Supplement Dates FDA Received: 01/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2011
• 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
• Patient Age: 46 YR