MAUDE Adverse Event Report: ALPHATEC SPINE INC TI 8.5 MM POLYAXIAL SCREW ASSY, 45 MM (TI-6AI-4V ELI); PEDICLE SCREW SPINAL FIXATION

Model Number	62085-45
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The international customer provided three (3) separate identifying lot numbers.It is unknown which belongs to the fractured polyaxial screw.Lot 687074 manufactured 2/20/2015.Lot 692540 manufactured 6/1/2015.Lot 692490 manufactured 6/5/2015.No evaluation possible at this time.The polyaxial has not been removed from the patient.It remains securely anchored within the l5 lumber vertebrae.Upon the receipt of additional information and/or the device, a follow up reported with be submitted.
Event or Problem Description
Follow up x-rays taken (b)(6) 2016 revealed the polyaxial screw located at the right l5 had fractured and broke.Revision surgery is scheduled for (b)(6) 2016.The zodiac degenerative spinal fixation system was originally implanted on (b)(6) 2015 from the l3 to l5.

• Brand Name: TI 8.5 MM POLYAXIAL SCREW ASSY, 45 MM (TI-6AI-4V ELI)
• Common Device Name: PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 5998183
• Report Number: 2027467-2016-00075
• Device Sequence Number: 18842111
• Product Code: KWP
• UDI-Device Identifier: 00844856003248
• UDI-Public: 00844856003248
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K042673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/07/2016

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 Model Number: 62085-45
• Device Catalogue Number: 62085-45
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2016
• Initial Report FDA Received Date: 10/04/2016
• 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: Other
• Patient Age: 65 YR