MAUDE Adverse Event Report: SPINE WAVE, INC. PROFICIENT POSTERIOR CERVICAL SPINE SYSTEM; POSTERIOR CERVICO-THORACIC FIXATION SYSTEM

Catalog Number	11-8999
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
At approximately 4 months post-operatively, it was noted on routine follow-up radiographs that the rod was dissociated from two screws heads at the c2 and c3 levels on one side of the multi-level cervico-thoracic construct with the appearance of loose locking screws at those levels.No intervention has been undertaken.The patient remains asymptomatic.

• Brand Name: PROFICIENT POSTERIOR CERVICAL SPINE SYSTEM
• Common Device Name: POSTERIOR CERVICO-THORACIC FIXATION SYSTEM
• Manufacturer (Section D): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton CT 06484
• MDR Report Key: 7404329
• Report Number: 3004638600-2018-00004
• Device Sequence Number: 173453
• Product Code: NKG
• UDI-Device Identifier: 10840642111217
• UDI-Public: 10840642111217
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K162639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 11-8999
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2018
• Initial Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1