MAUDE Adverse Event Report: ALPHATEC SPINE INC 4.0 MM FIXED ANGLE, SELF-TAPPING, HEXALOBE SCREW, 13 MM (TI-6AI-4V ELI); SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	71540-13
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No evaluation possible.The device has not been removed from the patient nor has the identifying lot number(s) been provided.Alphatec informed the patient that alphatec is a medical device manufacturer and cannot provide any medical advice.We strongly suggest she consult the implanting physician for medical guidance.
Event or Problem Description
Patient contacted alphatec directly alleging broken hardware in her cervical spine.One of the screws in her neck has broken as well as one has come loose.She is looking for information regarding this issue.The trestle luxe anterior cervical plating system was originally implanted on (b)(6) 2015.No other information has been provided or is known at this time.

• Brand Name: 4.0 MM FIXED ANGLE, SELF-TAPPING, HEXALOBE SCREW, 13 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: 5809380
• Report Number: 2027467-2016-00059
• Device Sequence Number: 370383
• Product Code: KWQ
• UDI-Device Identifier: 00844856067875
• UDI-Public: 00844856067875
• Combination Product (Y/N): N
• PMA/510(K) Number: K102820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 07/15/2016

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: 71540-13
• Device Catalogue Number: 71540-13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2016
• Initial Report FDA Received Date: 07/20/2016
• 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: 36 YR