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

Model Number	STM6030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/09/2016
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: INTERVERTEBRAL FUSION DEVICE, LUMBAR
• Manufacturer (Section D): CENTINEL SPINE, INC.; 900 airport rd, suite 3b; west chester PA 19380
• MDR Report Key: 6304105
• Report Number: 3007494564-2016-00004
• Device Sequence Number: 783180
• Product Code: OVD
• UDI-Device Identifier: 00815101021713
• UDI-Public: 00815101021713
• Combination Product (Y/N): N
• PMA/510(K) Number: K150643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2016
• Initial Report FDA Received Date: 02/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 74 YR