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

Model Number	71240-14
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information provided by the sales rep indicated the patient has no symptoms of discomfort or pain.The irregularity was only detected when the patient returned for a routine post-op checkup.The examination also revealed that a successful fusion/healing had been achieved.Revision surgery is not required at this time.An evaluation of the set screw is not possible.The implant has not been removed from the patient nor has the identifying lot number(s) been provided.Upon the receipt of additional information and/or the suspect implants a follow report will be submitted.
Event or Problem Description
Patient came in for 1 year visit.X-ray's show the two bottom screws snapped in half.The trestle luxe plating system was originally implanted on (b)(6) 2016.

• Brand Name: 4.0 MM VARIABLE ANGLE, SELF-DRILLING 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: 6581361
• Report Number: 2027467-2017-00041
• Device Sequence Number: 16344299
• Product Code: KWQ
• UDI-Device Identifier: 00844856067325
• UDI-Public: 00844856067325
• Combination Product (Y/N): N
• PMA/510(K) Number: K102820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/25/2017

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: 71240-14
• Device Catalogue Number: 71240-14
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2017
• Initial Report FDA Received Date: 05/22/2017
• 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