MAUDE Adverse Event Report: ALPHATEC SPINE INC SET SCREW (TI-6AL-4V ELI); PEDICLE SCREW SYSTEM

Model Number	47127
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No evaluation 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 product in question, a follow-up report will be submitted.
Event or Problem Description
Post-op x-rays taken (b)(6) 2019 revealed that both the set screws located on the right iliac had backed out of position.Loosening of the set screws enabled the distal end of the rod to detach from the tulip of the polyaxial screw.The patient is doing fine.Revision surgery is not needed at this time, nor is there any plan for additional surgery as a result of this event.The arsenal fixation system was originally implanted on (b)(6) 2018.

• Brand Name: SET SCREW (TI-6AL-4V ELI)
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 8288965
• Report Number: 2027467-2019-00001
• Device Sequence Number: 16632501
• Product Code: NKB
• UDI-Device Identifier: 00840967124582
• UDI-Public: (01)00840967124582
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K133221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2019

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: Health Professional
• Device Model Number: 47127
• Device Catalogue Number: 47127
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 01/30/2019
• 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: 64 YR