MAUDE Adverse Event Report: DEPUY SYNTHES SPINE DEVEX TI WEDGED CAGE, 28X10; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	186428010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Neurological Deficit/Dysfunction (1982); Dizziness (2194)
Date of Event	01/01/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported by legal that patient had several post op issues following posterior spinal instrumentation with depuy expedium (l5-s1).Left l5-s1 transforaminal lumbar interbody fusion with placement of a depuy devex 10 x 28 transforaminal lumbar interbody fusion titanium cage and anterior spinal fusion with autograft at l5-s1.Uneventful surgery per op report.Nothing out of the ordinary.
Additional Manufacturer Narrative
Product complaint # (b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DEVEX TI WEDGED CAGE, 28X10
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7259339
• Report Number: 1526439-2018-50116
• Device Sequence Number: 13700022
• Product Code: MQP
• UDI-Device Identifier: 10705034118826
• UDI-Public: 10705034118826
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: K023835
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/24/2018

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 Model Number: 186428010
• Device Catalogue Number: 186428010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 01/09/2020; 01/31/2020
• Initial Report FDA Received Date: 02/09/2018
• Supplement Report FDA Received Date: 01/14/2020; 02/05/2020
• 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: Other
• Patient Age: 46 YR