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

Model Number	73724
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection confirmed that one of the locking tabs has been completely removed/broken from the instrument.The detached section was returned with the remainder of the device.Additionally, the corresponding halves of the open distal end are no longer cylindrical as manufactured.The evidence indicates that the root cause is related to excessive torsional loads to the reducer during rod reduction maneuver.
Event or Problem Description
Locking tab snapped off after rod was fully seated within tulip of screw.

• 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: 9792719
• Report Number: 2027467-2020-00017
• Device Sequence Number: 16594329
• Product Code: LXH
• UDI-Device Identifier: 00844856041691
• UDI-Public: (01)00844856041691(10)6729101
• 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): 02/11/2020

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: 73724
• Device Catalogue Number: 73724
• Device Lot Number: 6729101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 03/05/2020
• 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