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

Model Number	73772
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the returned instrument found no manufacturing, processing or design related irregularities.The instrument was found to be properly manufactured and released in accordance with the device master record.A previous investigation found that the failure mode observed in this type of event, is due to imparting excessive torsional loads to the mating instrument (reducer) during the rod reduction maneuver.Excessive load can be applied due to a tolerance gap condition between the reducer and extenders.The over-torque observation was corroborated by the two design interface analyses (dias) that were performed on the reducer/screw extender interfaces.
Event or Problem Description
During the surgery, the surgeon performed the reduction of the screw with strength, because it was difficult to move the reducer when reduction of the l4 screw left side.Then the tip part (jointed parts with the screw) of the reduction extender was broken.As the result, it was necessary to replace the screw due to the breakage of the instrument.When replacing the screw, the reducer did not move smoothly once again, but the set screw engaged slightly and the surgeon continued the fixation without any extra reduction.The surgery was completed with one-hour delay.

• Brand Name: ILLICO MIS POSTERIOR FIXATION SYSTEM
• Common Device Name: LXH
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 10977212
• Report Number: 2027467-2020-00049
• Device Sequence Number: 11571968
• Product Code: LXH
• UDI-Device Identifier: 00840967192901
• UDI-Public: (01)00840967192901(10)7180101
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/10/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 73772
• Device Catalogue Number: 73772
• Device Lot Number: 7180101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 12/09/2020
• 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: Hospitalization