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

Model Number	11-8999
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
After approximately 5 months post-operatively, a surgical procedure was performed to replace locking screws that had dissociated from the screw heads in a multi-level cervico-thoracic construct.
Additional Manufacturer Narrative
The explanted locking screws were returned for evaluation.Post-operative radiographic images were received confirming the condition reported.Visual examination found wear and deformation consistent with the reported condition and use in a pedicle screw construct.Further evaluation found no functional defects and the production records did not identify any non-conformances to specification.Based on the results of the investigation, a definitive conclusion could not be drawn.

• 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 drive; suite 210; shelton CT 06484
• Manufacturer Contact: ronald smith ; 3 enterprise drive; suite 210; shelton, CT 06484 ; 2039449494
• MDR Report Key: 14594654
• Report Number: 3004638600-2022-00003
• Device Sequence Number: 11277204
• 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: 2021
• Device Explanted Year: 2022
• 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): 05/03/2022

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: 11-8999
• Device Catalogue Number: 11-8999
• Device Lot Number: 662W220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female