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

Model Number	11-7275
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately 8 months post-operatively following pedicle screw fixation with interbody implant, a patient reported pain.A broken rod in the pedicle screw construct was identified on radiograph.No surgical intervention has been performed.
Event or Problem Description
Approximately 8 months post-operatively following pedicle screw fixation with an interbody implant, a patient reported pain.A broken rod in the pedicle screw construct was identified on radiograph.A surgical procedure was performed to replace the construct.At the time of this procedure, the surgeon identified a pars defect at the operative level.The construct was replaced and extended.
Additional Manufacturer Narrative
Based on additional information and device receipt and evaluation the following fields were changed: b1 to adverse event, b2 to required intervention, b5 to update the event description, d9 to indicate device received with date, h1 to serious injury, h3 to device evaluated yes and h6 for updated codes.New information was added to the following fields: d4, d6b and h4.The device was returned for evaluation.Visual inspection was performed and the reported rod breakage was confirmed.The damage observed was consistent with the application, use and event reported.Review of production records found no discrepancies related to this event.Based on the results of our evaluation, a root cause associated with the device could not be identified.The surgeon associated this event to a pars defect in the patient anatomy.

• Brand Name: SALVO SPINE SYSTEM
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton CT 06484
• MDR Report Key: 11372958
• Report Number: 3004638600-2021-00003
• Device Sequence Number: 3816077
• Product Code: MNH
• UDI-Device Identifier: 10840642139099
• UDI-Public: 10840642139099
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K183954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11-7275
• Device Catalogue Number: 11-7275
• Device Lot Number: 543U161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention