MAUDE Adverse Event Report: ALPHATEC SPINE INC ILLICO MIS POSTERIOR FIXATION SYSTEM; PEDICLE SCREW SYSTEM

Model Number	73875-40
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned implant is currently under investigation.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem Description
After the final tightening, the surgeon found that the set screw popped off by imaging.The surgeon retrieved the set screw and tried to re-install it but could not.The images also confirmed that the polyaxial screw head/tulip was broken.
Additional Manufacturer Narrative
An evaluation of the returned polyaxial screw found one side of the tulip has been completely broken/detached from the remainder of the implant.Additionally, both the set screw & polyaxial screw appear to have gouges and markings indicative of cross threading.It appears likely that the anti-torque may not have been completely seated and when forces were placed on the screw during the final tightening process.

• Brand Name: ILLICO MIS POSTERIOR FIXATION SYSTEM
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 10651167
• Report Number: 2027467-2020-00044
• Device Sequence Number: 11565193
• Product Code: NKB
• UDI-Device Identifier: 00844856043329
• UDI-Public: (01)00844856043329(10)716865
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2020

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: No Information
• Device Model Number: 73875-40
• Device Catalogue Number: 73875-40
• Device Lot Number: 716865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 11/05/2020
• 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