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

Model Number	73772
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It appears that root cause is related to excessive torsional loads to the reducer during rod reduction maneuver.The over torqueing condition caused the two mates (reducer & screw extender) to become stuck/fused together.Disassembly of the union would likely destroy any traces of subjective evidence.
Event or Problem Description
One of the tabs broke off the screw extender while reducing the rod.The detached section was removed from the patient without issue and the rod fully reduced with no further complication.The event cause no patient harm.

• Brand Name: ILLICO MIS POSTERIOR FIXATION SYSTEM
• Common Device Name: LXH
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad, ca
• MDR Report Key: 9732174
• Report Number: 2027467-2020-00011
• Device Sequence Number: 765272
• Product Code: LXH
• UDI-Device Identifier: 00840967192901
• UDI-Public: (01)00840967192901
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2020

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: Health Professional
• Device Model Number: 73772
• Device Catalogue Number: 73772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 02/20/2020
• 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