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

Model Number	11-4002
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Multiple locking screws were removed and returned for evaluation along with a rod and a pedicle screw.Review of production records identified no issues related to production or inspection that may be associated to the reported event.Evaluation is in progress.
Event or Problem Description
At an unspecified time post-operatively, a surgical procedure was performed to address a loose locking screw in a pedicle screw construct that was identified on radiograph.
Additional Manufacturer Narrative
D6a: new data - implant date.H3: device evaluated = yes.H6: investigation findings and investigation conclusion codes updated.H10: mfg narrative update: the removed locking screws and concomitant hardware (ie.Rod, screw) were returned and evaluated.Due to wear related to use, the lot marking of the locking screws was illegible therefore a review of all potential production records was undertaken with no abnormalities found.Visual inspection identified marking and deformation consistent with the reported event.Based on evaluation findings and the information available, the exact root cause could not be determined.

• Brand Name: SNIPER 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 drive; ste 210; shelton, CT 06484 ; 2039449494
• MDR Report Key: 17139881
• Report Number: 3004638600-2023-00005
• Device Sequence Number: 20277073
• Product Code: NKB
• UDI-Device Identifier: 10840642105605
• UDI-Public: 10840642105605
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 05/19/2023

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: 11-4002
• Device Catalogue Number: 11-4002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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