MAUDE Adverse Event Report: INTERVENTIONAL SPINE, INC. INTERVENTIONAL SPINE; SYSTEM, FACET SCREW SPINAL DEVICE

Catalog Number	9024-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Spinal Column Injury (2081); Not Applicable (3189)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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, revision surgery for the interventional spine facet screw (product code/description below) occurred on friday (b)(6) 2018.Revision surgery went well with a depuy spine revision set.No further information known.Part number for ispine screw 9024-01 (unrecognized part in unity) reason for revision is unknown.

• Brand Name: INTERVENTIONAL SPINE
• Common Device Name: SYSTEM, FACET SCREW SPINAL DEVICE
• Manufacturer (Section D): INTERVENTIONAL SPINE, INC.; 13700 alton pkwy.; suite 160; irvine CA 92618
• MDR Report Key: 7316144
• Report Number: 1526439-2018-50204
• Device Sequence Number: 19175537
• Product Code: MRW
• UDI-Device Identifier: 00811954013219
• UDI-Public: 00811954013219
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K082795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/14/2018

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 Catalogue Number: 9024-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 03/06/2018
• 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: Required Intervention