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

Catalog Number	21-8320
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a surgical procedure, one screw broke during insertion.The device was removed and the case continued without issue.No patient consequence as a result.
Additional Manufacturer Narrative
Fields updated: h6 updated to add codes for investigation findings and investigation conclusion.

• 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; ste 210; shelton, CT 06484 ; 2039449494
• MDR Report Key: 19562760
• Report Number: 3004638600-2024-00006
• Device Sequence Number: 7501499
• Product Code: NKG
• UDI-Device Identifier: 10840642119107
• UDI-Public: 10840642119107
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2024

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: 21-8320
• Device Lot Number: 661Z084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2024
• 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