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

Catalog Number	11-4646
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation in progress; no conclusion can be made at this time.Upon completion of the evaluation, a follow up supplemental report shall be submitted.
Event or Problem Description
During placement of a pedicle screw for lumbar fixation, the surgeon experienced difficulty reducing the rod at the l4-l5 level.Subsequently, the surgeon noticed the screw was separated.The screw was removed and replaced intraoperatively.
Additional Manufacturer Narrative
The returned device was evaluated and the reported event was confirmed.The returned device displayed visual indications of use in a manner that exceeded the strength of the assembly.Units from inventory were inspected and were found to meet specifications.A review of the dhr found the product met release requirements.

• Brand Name: SNIPER 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: 7567462
• Report Number: 3004638600-2018-00007
• Device Sequence Number: 16659785
• Product Code: MNH
• UDI-Device Identifier: 10840642106442
• UDI-Public: 10840642106442
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 11-4646
• Device Lot Number: 941T05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 06/04/2018
• Supplement Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1