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

Catalog Number	11-4001
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/05/2018
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 a surgical procedure to extend a pedicle screw construct, the surgeon noted loose locking screws.The original pedicle screw construct had been implanted approximately eighteen months earlier.The surgeon replaced the locking screws and extended the construct as planned.
Additional Manufacturer Narrative
Returned for evaluation were three locking screws.The exact locking screws involved in this event were not identified, however.A thorough visual examination was performed.All units exhibited signs of wear consistent with surgical use.The locking screw threads displayed no abnormalities and functioned as intended upon evaluation within a screw.The reported condition was confirmed by review of a radiographic image.A review of device history records found no non-conformances to specification.Based on the results of our evaluation, no definitive conclusion can be drawn.

• Brand Name: SNIPER SPINE SYSTEM LOCKING SCREW
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SPINE WAVE, INC.; 3 enterprise drive; suite 302; shelton CT 06484
• MDR Report Key: 7496900
• Report Number: 3004638600-2018-00006
• Device Sequence Number: 11253638
• Product Code: MNH
• UDI-Device Identifier: 10840642105599
• UDI-Public: 10840642105599
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K160003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2018

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: 11-4001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1