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

Catalog Number	11-4646
Health Effect - Clinical Code	Fall (1848)
Date of Event	05/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Returned for evaluation were the upper portion of two broken pedicle screws consistent with the event as reported.Due to the length of time in situ following the initial breakage, the material on the surface of the screws at the break was burnished preventing further evaluation of the fracture surface.Review of the dhr found no device issues for the identified production lot.All other parts returned with these screws were visually inspected and were found to display wear patterns consistent with normal use.
Event or Problem Description
Approximately one year post-operatively following a posterior lumbar interbody fusion, two broken screws in a one level pedicle screw construct were noted on radiograph.A surgical procedure was performed approximately six months later to remove the pedicle screw construct including the broken screw heads, the two rods and four locking caps.The surgeon did not replace the construct.The surgeon has noted that this patient experienced a fall while skiing a short time after the initial implant surgery which he has associated to this event.

• 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: 7639645
• Report Number: 3004638600-2018-00008
• Device Sequence Number: 2413065
• 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: K100605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/31/2017

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: Physician
• Device Catalogue Number: 11-4646
• Device Lot Number: 661P134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/26/2018
• 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