MAUDE Adverse Event Report: SPINE WAVE, INC. SALVO SPINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	11-6401
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted locking screws and other hardware were returned for evaluation.The results of the evaluation are inprocess.
Event or Problem Description
At an unspecified time 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 hardware was removed and replaced at that time.
Additional Manufacturer Narrative
Returned were two (2) locking screws and in addition the other hardware that was removed during the procedure including two (2) screw-yoke assemblies and two (2) connectors with locking screws.The spinal rods used in this pedicle screw construct were not returned.The returned devices were evaluated.Visual inspection of the all devices found indicators consistent with use in a pedicle screw construct.One locking screw and one screw assembly displayed deformation consistent with the reported event.Review of production records did not identified issues related to production or inspection that may be associated to the reported event.Based on the evaluation findings, the information available and as not all devices used in the construct were available for evaluation, the exact root cause of this event could not be defiantly established.

• Brand Name: SALVO SPINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW 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 dr.; suite 210; shelton, CT 06484 ; 2039449494
• MDR Report Key: 15473427
• Report Number: 3004638600-2022-00004
• Device Sequence Number: 14161110
• Product Code: NKB
• UDI-Device Identifier: 10840642163704
• UDI-Public: 10840642163704
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K202476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 08/26/2022

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: 11-6401
• Device Catalogue Number: 11-6401
• Device Lot Number: 664V171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2022
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2021
• 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: Unknown