MAUDE Adverse Event Report: ALPHATEC SPINE INC ANTERIOR CERVICAL PLATE ASSEMBLY, 3-LEVEL, 054 MM (TI-6AI-4V ELI, NITINOL); SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	71003-054
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation of the trestle luxe screws is not possible at this time.The implants have not been removed from the patient nor has the identifying lot number(s) been provided.Upon the receipt of additional information and/or the return of the implant(s) a follow up report will be submitted.
Event or Problem Description
Screw back out 6 weeks postop.Obvious subsidence at c7 superior endplate.Unclear why locking mechanism failed to prevent screw back out.The trestle luxe anterior cervical plating system was originally implanted on (b)(6) 2017.

• Brand Name: ANTERIOR CERVICAL PLATE ASSEMBLY, 3-LEVEL, 054 MM (TI-6AI-4V ELI, NITINOL)
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 6584572
• Report Number: 2027467-2017-00039
• Device Sequence Number: 16162900
• Product Code: KWQ
• UDI-Device Identifier: 00844856067110
• UDI-Public: 00844856067110
• Combination Product (Y/N): N
• PMA/510(K) Number: K102820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/26/2017

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?: Yes
• Operator of Device: Physician
• Device Model Number: 71003-054
• Device Catalogue Number: 71003-054
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2017
• Initial Report FDA Received Date: 05/23/2017
• 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: 58 YR