MAUDE Adverse Event Report: CAREFUSION V. MUELLER NEURO/SPINE SHADOW-LINE; SPINAL DISTRACTION SCREW

Model Number	S-0088
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/14/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Rust line material noted on the spinal distraction screws.Checked the boxes of 5 and notes some were rusted and others were not.Twenty eight screws removed from stock.V.Mueller at neuro/spine shadow-line spinal distraction screw sterile, 12mm ref-s-0088 llot 876501(7) 879272(2) 876505(6) ref-s-0089 lot 879299(4) 876473(5) 879298(4).

• Brand Name: V. MUELLER NEURO/SPINE SHADOW-LINE
• Common Device Name: SPINAL DISTRACTION SCREW
• Manufacturer (Section D): CAREFUSION; vemon hills IL 60061
• MDR Report Key: 5744514
• Report Number: MW5062990
• Device Sequence Number: 3242
• Product Code: MQP
• UDI-Device Identifier: 20885403004237
• UDI-Public: (01)20885403004237
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/20/2016
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: S-0088
• Device Lot Number: 876504
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1