MAUDE Adverse Event Report: SPINECRAFT ASTRA SPINE SYSTEM; SET SCREW

Catalog Number	A5S-T30
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review was conducted of all applicable material, manufacturing, storage and distribution records for the device related to this incident, the associated device and the torque limiting handles used to tighten the screw.The records indicated that all product lots for these items were manufactured within specification, maintained and distributed in accordance with all approved company procedures.Device evaluation of the returned device and a controlled device from the same lot was performed in an attempt to replicate conditions necessary to create a scenario where reported event is possible.During final tightening of set screws, it has been normally observed that the rod creates a sweeping burnish mark on the bottom surface of the set screw akin to a windshield wiper mark.However, this mark was distinctly missing on the set screw related to this incident.This unmarked area would suggest that the set screw never experienced proper final tightening.The remaining markings would have been caused by the movement of the rod, once loosening propagated.Also, it can be noted that there is no specific damage to the threads, which would be expected if there was cross-threading or some other event that would have hindered the set screw from seating against the rod during final tightening.At this time, there are no other known factors that would have prevented the set screw from tightening against the rod.Based on the evidence from the observations and testing performed, no probable root cause(s) for this incident could be determined until and unless further information becomes available.Therefore, no corrective action is deemed necessary at this time.The patient was revised successfully and is reportedly doing well.
Event or Problem Description
It was discovered on a post-op follow up visit that one of the set screws is loose.

• Brand Name: ASTRA SPINE SYSTEM
• Common Device Name: SET SCREW
• Manufacturer (Section D): SPINECRAFT; 777 oakmont lane, suite # 200; westmont 60559 5511
• MDR Report Key: 6431316
• Report Number: 3004717358-2017-00001
• Device Sequence Number: 511859
• Product Code: NKB
• UDI-Device Identifier: M824A5ST301
• UDI-Public: +M824A5ST301/$$7120529$
• Combination Product (Y/N): N
• PMA/510(K) Number: K150417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/24/2017

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: No Information
• Device Catalogue Number: A5S-T30
• Device Lot Number: 120529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2017
• Initial Report FDA Received Date: 03/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: A5P-6545E-C
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR