MAUDE Adverse Event Report: ALPHATEC SPINE INC 4.0 MM VARIABLE ANGLE, SELF-TAPPING HEXALOBE SCREW, 14 MM (TI-6AI-4V ELI); SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	71340-14
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the trestle luxe screws is not possible at this time.The explanted construct has 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 images found that the trestle luxe screw located at the c5 cervical vertebrae had backed out of position.Revision surgery was conducted to remove and replace the hardware positioned at the c5-c7.

• Brand Name: 4.0 MM VARIABLE ANGLE, SELF-TAPPING HEXALOBE SCREW, 14 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: 5919040
• Report Number: 2027467-2016-00066
• Device Sequence Number: 16266840
• Product Code: KWQ
• UDI-Device Identifier: 00844856067431
• UDI-Public: 00844856067431
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K102820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/10/2016

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: Physician
• Device Model Number: 71340-14
• Device Catalogue Number: 71340-14
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2016
• Initial Report FDA Received Date: 08/31/2016
• 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: Hospitalization
• Patient Age: 60 YR