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

Model Number	47027
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No evaluation possible.The identifying lot numbers have not been provided.The explanted construct was given to the patient upon removal.
Event or Problem Description
Two arsenal set screws (47027) were found detached from the tulip of the mating polyaxial screws located at both the right and left sides of the s1.The patient was reported to have already fused/healed.Revision surgery was conducted on (b)(6) 2016 to remove the l4-s1 construct.

• 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: 6017885
• Report Number: 2027467-2016-00080
• Device Sequence Number: 19292307
• Product Code: NKB
• UDI-Device Identifier: 00844856070325
• UDI-Public: 00844856070325
• Combination Product (Y/N): N
• PMA/510(K) Number: K133221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/16/2016

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?: Yes
• Operator of Device: Physician
• Device Model Number: 47027
• Device Catalogue Number: 47027
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2016
• Initial Report FDA Received Date: 10/11/2016
• 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: 47 YR