MAUDE Adverse Event Report: ALPHATEC SPINE INC 4.0 MM FIXED ANGLE, SELF-TAPPING, HEXALOBE SCREW, 16 MM (TI-6AI-4V ELI); SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	71540-16
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the trestle luxe screw is not possible at this time.The removed implants have not been returned for evaluation nor have 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
Post op x-rays taken on (b)(6) 2016 found the trestle luxe screw located on the left side of the c6 cervical vertebrae had backed out past locking mechanism.Revision surgery was conducted on (b)(6) 2017.The trestle luxe anterior cervical plating system was originally implanted on (b)(6) 2016 during an acdf (anterior cervical discectomy fusion) from c4 thru c6.

• Brand Name: 4.0 MM FIXED ANGLE, SELF-TAPPING, HEXALOBE SCREW, 16 MM (TI-6AI-4V ELI)
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 6482501
• Report Number: 2027467-2017-00013
• Device Sequence Number: 1053893
• Product Code: KWQ
• UDI-Device Identifier: 00844856067905
• UDI-Public: 00844856067905
• Combination Product (Y/N): N
• PMA/510(K) Number: K102820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2017

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: Physician
• Device Model Number: 71540-16
• Device Catalogue Number: 71540-16
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2017
• Initial Report FDA Received Date: 04/11/2017
• 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: Hospitalization
• Patient Age: 56 YR