MAUDE Adverse Event Report: SPINE WAVE, INC. SNIPER SPINAL SYSTEM; PEDICAL SCREW SYSTEM

Model Number	11-4645
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event and the information provided herein are as reported in the sus voluntary event report mw5103083.
Event or Problem Description
This event was reported to fda as a sus voluntary event report (mw5103083).It was reported that following heavy lifting by the patient, pain was experienced.Subsequent radiographic imaging showed "loosening involving the pedicle screw fragments within the pedicles." a surgical procedure was performed to remove the instrumentation.The broken pedicle screws were unable to be removed.
Additional Manufacturer Narrative
This follow-up report includes updates to the following fields based on receipt and evaluation of the device: d9 (date returned to mfg), h4 (device manufacture date).The following fields were updated based on return of product, corrected data and evaluation findings: d4 (catalog #, lot #, udi), d9 (device availability), h3 (device evaluation by mfg) and and h6 (adverse event codes).

• Brand Name: SNIPER SPINAL SYSTEM
• Common Device Name: PEDICAL SCREW SYSTEM
• Manufacturer (Section D): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton CT 06484
• Manufacturer (Section G): SPINE WAVE, INC.; 3 enterprise drive; ste 210; shelton CT 06484
• Manufacturer Contact: ronald smith ; 3 enterprise drive; ste 210; shelton, CT 06484 ; 2039449494
• MDR Report Key: 12509847
• Report Number: 3004638600-2021-00005
• Device Sequence Number: 3321925
• Product Code: MNH
• UDI-Device Identifier: 10840642106435
• UDI-Public: 10840642106435
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K152174
• 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: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 11-4645
• Device Catalogue Number: 11-4540
• Device Lot Number: 622K122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2012
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown