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

Model Number 11-6401

Device Problem Separation Failure (2547)

Patient Problem Failure of Implant (1924)

Event Date 08/22/2022

Event Type  Injury  

Manufacturer Narrative

The explanted locking screws and other hardware were returned for evaluation.The results of the evaluation are inprocess.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 300554004
• Report Number: 3004638600-2022-00004
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10840642163704
• UDI-Public: 10840642163704
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention