MAUDE Adverse Event Report: CENTINEL SPINE, INC. STALIF MIDLINE; INTERVERTEBRAL FUSION DEVICE, LUMBAR

Model Number STM6030

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 12/09/2016

Event Type  Injury  

Manufacturer Narrative

Review of sterilization and manufacturing records indicate no abnormalities or non-conformances that would have contributed to this issue.All product accepted to stock were evaluated to be within specifications with all inspection and certification present and correct.Review of complaint log shows 1 other complaint and mdr filed for an infection event in 2013 ((b)(4)) for a centinel spine cervical product.This is the first complaint regarding an infection in relation to a lumbar product.The rates are within those evaluated for probability of occurence and fully mitigated within the corresponding risk assessment fmeas.Device not returned to manufacturer.

Event Description

A 2-level alif at l4-5 and l5-s1 was performed on the patient on (b)(6) 2016.They brought the patient back to the or to treat an infection they had determined was somewhere internal near the l4-5 interbody area.Upon exploration, they found an infected area trans-psoas in that area that also extended into the interbody area where the cage was placed.They removed the screws and the cage and discovered that the infection had found it's way into the disc space, dissolved the bone graft material and loosened the interface between the cage and the endplates.One of the endplates appeared to be fractured, so the surgeon decided not to replace the cage, and instead to thoroughly clean and wash the area, pack the disc space with cancellous chips and other bone graft material and come back later with posterior pedicle screws to stabilize the joint.The do not think the infection is device related, but it is not known what caused the infection or where it originated.

• Brand Name: STALIF MIDLINE
• Type of Device: INTERVERTEBRAL FUSION DEVICE, LUMBAR
• Manufacturer (Section D): CENTINEL SPINE, INC.; 900 airport rd, suite 3b; west chester PA 19380
• Manufacturer (Section G): INTAI TECHNOLOGY CORP.; 9 jinke rd; taichung, r.o.c 40852 ; TW 40852
• Manufacturer Contact: hayley-ann parry ; 900 airport rd, suite 3b; west chester, PA 19380 ; 4848878814
• MDR Report Key: 6304105
• MDR Text Key: 66600746
• Report Number: 3007494564-2016-00004
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 00815101021713
• UDI-Public: 00815101021713
• Combination Product (y/n): N
• PMA/PMN Number: K150643
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2019
• Device Model Number: STM6030
• Device Catalogue Number: STM6030
• Device Lot Number: 2015-143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/29/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 74 YR