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

Catalog Number	11-8999
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
At approximately 8 weeks post-operatively, a loose locking screw and spinal rod in a pedicle screw construct were identified.No intervention has been taken at this time.
Additional Manufacturer Narrative
The device was not removed and therefore not returned for evaluation.Attempts to obtain additional details have been unsuccessful.Based on the information available, the exact root cause of this event could not be established.

• 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
• Manufacturer (Section G): SPINE WAVE, INC.; 3 enterprise dr.; suite 210; shelton CT 06484
• Manufacturer Contact: ronald smith ; 3 enterprise drive; suite 210; shelton, CT 06484 ; 2039449494
• MDR Report Key: 17500369
• Report Number: 3004638600-2023-00010
• Device Sequence Number: 12360461
• Product Code: NKG
• UDI-Device Identifier: 10840642111217
• UDI-Public: 10840642111217
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/11/2023

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: Health Professional
• Device Catalogue Number: 11-8999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown