MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INVICTUS; CROSS CONNECTOR INSERTER

Model Number	16021
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records 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.Instrument (16021) was used to supplement a final driver (16022).The 16021 universal cross connector inserter is not designed for the input loads of the final driver sequence.
Event or Problem Description
The torque handle did not unlock the cross connector so the inserter was used but it broke inside the cross connector.No injury to the patient but a piece of the inserter driver was retained in the patient.

• Brand Name: INVICTUS
• Common Device Name: CROSS CONNECTOR INSERTER
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• MDR Report Key: 11822134
• Report Number: 2027467-2021-00024
• Device Sequence Number: 4308488
• Product Code: LXH
• UDI-Device Identifier: 00190376284637
• UDI-Public: (01)00190376284637(10)8693301
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K203056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/14/2021

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: No Information
• Device Model Number: 16021
• Device Catalogue Number: 16021
• Device Lot Number: 8693301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 05/13/2021
• 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