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	Pain (1994)
Date of Event	04/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review was conducted of all applicable material, manufacturing, storage and distribution records.The records indicated that all product lots for this item shipped 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 commonly 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.It is unknown what prevented "proper" contact between the set screw and the rod during the final tightening of set screw.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
Surgeon performed a revision surgery on (b)(6) 2016 to replace a set screw that was discovered to be loose.The original surgery was completed on (b)(6) 2016.

• 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: 5645754
• Report Number: 3004717358-2016-00001
• Device Sequence Number: 10807969
• Product Code: NKB
• UDI-Device Identifier: M824A5ST301
• UDI-Public: M824A5ST301
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K150417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2016

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: Health Professional
• Device Catalogue Number: A5S-T30
• Device Lot Number: 92115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2016
• Initial Report FDA Received Date: 05/10/2016
• 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
• Patient Age: 70 YR