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

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/13/2017

Event Type  malfunction  

Manufacturer Narrative

The information in this report was obtained from the maude database; due to the limited amount of information available, no additional follow up details could be obtained regarding this event or the device allegedly involved in this event.

Event Description

During a routine review of the fda maude database, this report, mdr report (b)(4), was identified.Based on the limited information available, no additional information could be obtained regarding this event.

Manufacturer Narrative

Additional information entered in fields (date of event) and (description of event).

Event Description

The following information is as written in the report number (b)(4) found in the public maude database."a screw was inserted while attached to screw inserter that consists of two parts.When it was disconnected from the extension, part of the extension at the distal end broke off.This happened two times.".

• Brand Name: SNIPER PEDICLE SCREW SYSTEM
• Type of Device: INSTRUMENT
• Manufacturer (Section D): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton 06484
• Manufacturer (Section G): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton CT 06484
• Manufacturer Contact: ronald smith ; 3 enterprise drive; suite 210; shelton, CT 06484 ; 2039449494
• MDR Report Key: 6862759
• MDR Text Key: 86509909
• Report Number: 3004638600-2017-00007
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• PMA/PMN Number: K100605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 08/14/2017

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?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: 08/14/2017
• Initial Date FDA Received: 09/13/2017
• Supplement Dates Manufacturer Received: 08/14/2017
• Supplement Dates FDA Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1