MAUDE Adverse Event Report: SPINE WAVE, INC. ANNEX IMPLANT HALF JOG STRAIGHT; ADJACENT LEVEL SYSTEM

Catalog Number	11-5121
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Returned was one of the two adjacent level devices.The second device was discarded by the hospital.Also returned were the two (2) spinal rods and two (2) locking screws removed from the construct.The returned devices were evaluated.Visual inspection of the returned devices found indicators consistent with use in a pedicle screw construct extension.Unexpected wear and deformation was observed on the spinal rods consistent with the reported event.Further evaluation of the device hook connector found no functional defects.A review of the device history production records for the subject devices for which production lots were identified found these products all met specifications for release.Based on the results of our evaluation, a definitive conclusion could not be drawn.
Event or Problem Description
Approximately one year and nine months post-operatively following the extension of a pedicle screw construct using the devices, a surgical procedure was performed to address slippage of the hooks on the spinal rods in the construct.The devices were removed and replaced successfully.

• Brand Name: ANNEX IMPLANT HALF JOG STRAIGHT
• Common Device Name: ADJACENT LEVEL SYSTEM
• Manufacturer (Section D): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton CT 06484
• MDR Report Key: 8551062
• Report Number: 3004638600-2019-00006
• Device Sequence Number: 374003
• Product Code: MNI
• UDI-Device Identifier: 10840642102772
• UDI-Public: 10840642102772
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132403
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2019

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: 11-5121
• Device Lot Number: 664N109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 04/25/2019
• 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